Clinical and structural outcomes of neocommissural alignment in transaxillary and transcarotid transcatheter aortic valve implantation with a self-expandable transcatheter heart valve.

Objectives: This study analyzes neocommissural alignment and the clinical and hemodynamic outcomes after transaxillary and transcarotid implantation of the Acurate neo2 transcatheter heart valve. Methods: We performed a retrospective, single-center analysis of early outcomes after transaxillary and transcarotid implantation of the Acurate neo2 transcatheter heart valve. Primary outcomes were neocommisural alignment, in-hospital mortality, and valve hemodynamic performance. Commissural alignment between native and transcatheter heart valves was assessed by transesophageal echocardiogram before and after the procedure. Results: Between October 2021 and November 2022, 40 consecutive patients were treated with the Acurate neo2 through a transaxillary or transcarotid approach. Access was achieved via the left subclavian artery in 30 cases and the left common carotid artery in 10 cases, with a mean vessel diameter of 6.7 mm. Implants most commonly used were size M (37.5%), L (35%), and S (27.5%). On the basis of transesophageal echocardiogram analysis, there was no significant difference in mean commissural orientation between native (mean, 65.1°; SD, 41.3°) and neocommissures (mean, 64°; SD, 44.1°) (P = .661). Mean commissural orientation did not significantly differ between native and neocommissures (P = .661). Optimal alignment or mild commissural misalignment was achieved in 99.5% of cases. There were no cases of severe commissural misalignment. Postprocedural mean values for peak and mean gradients were 12.7 mm Hg and 5.2 mm Hg, respectively. There were 2 cases of moderate paravalvular leak and 4 cases of mild paravalvular leak. Conclusions: This patient-specific technique for transaxillary and transcarotid insertion of the Acurate neo2 delivery system prevents implantations with more than mild commissural misalignment and with a high device success rate.

Non-contrast transoesophageal echo-guided transapical transcatheter aortic valve replacement: 10-year experience of a renoprotective strategy.

OBJECTIVES: This study aims to evaluate the efficacy, safety and long-term outcomes of a renoprotective non-contrast, transoesophageal echocardiography-guided transapical (TA) transcatheter aortic valve replacement (TAVR) strategy with a balloon-expandable prosthesis, as well as to determine its impact on renal function. METHODS: Between 2009 and 2019, 200 consecutive patients underwent a non-contrast, transoesophageal echocardiography-guided TA TAVR with a balloon-expandable prosthesis. RESULTS: The device success rate was 95.5%. Transoesophageal echocardiography-guided deployment demonstrated a low rate of procedure-related complications: 9.5% of acute kidney injury, 8% postoperative bleeding, 6% low-cardiac output, 4.5% postprocedural aortic regurgitation ≥+2, 4% implantation of permanent pacemaker and 2% stroke. There were no significant differences between preoperative and on discharge estimated glomerular filtration rate (53.9 ± 22.2 vs 54.3 ± 22.9 ml/min/1.73 m2, P = 0.60). Logistic regression analysis confirmed postoperative bleeding as an independent predictor for acute kidney injury (odds ratio (OR) 11.148, 95% confidence interval 3.537-35.140, P < 0.001). In-hospital mortality was 7.5%. The mean follow-up was 48.5 ± 39.9 months. Renal function and patient's chronic kidney disease stage did not significantly vary during follow-up. Long-term cumulative survival at 1, 5 and 10 years was 84.2 ± 0.027%, 42.9 ± 0.038% and 32.5 ± 0.044%, respectively. Renal function affected on neither in-hospital mortality nor long-term survival. CONCLUSIONS: Non-contrast, transoesophageal echocardiography-guided TA TAVR is a safe and reproducible technique with a low incidence of periprocedural complications that avoids the use of contrast and mitigates the incidence of acute kidney injury.

Postoperative Plasma Mitochondrial DNA and Cytokine Profiles of Elderly Patients Undergoing Minimally Invasive Aortic Valve Replacement.

INTRODUCTION: Mitochondrial DNA (mtDNA) is gaining increasing interest as a marker of cellular damage and could also act as an inflammatory mediator in cardiopulmonary bypass induced postoperative inflammatory response. Although minimally invasive heart valve surgery reportedly reduces inflammation, the mtDNA and cytokine profile in this context remains unclear. MATERIALS AND METHODS: Here, we report a prospective series of 40 elderly patients with aortic stenosis who underwent bioprosthetic aortic valve replacement (AVR) through upper ministernotomy with either a sutureless (n = 20) or a conventional (n = 20) valve. Primary end points included serial plasma levels of mtDNA (T1: at baseline; T2: 4 hours after surgery; and T3: 24s hour after surgery), cytokines (interleukin-6 [IL-6], tumor necrosis factor-α [TNF-α]), and myocardial necrosis biomarkers (MNBs), whereas secondary end points included clinical and echocardiographic data. RESULTS: Significant increases in the postoperative plasma levels (T2) of mtDNA, cytokines, and MNBs were observed in all patients. The postoperative plasma levels of mtDNA, TNF-α, and MNBs showed no significant differences between the treatment groups, although there was a trend toward lower levels in the sutureless group. The decreases in aortic cross-clamp and cardiopulmonary bypass times seen in the sutureless group were associated with significant lower postoperative levels (T2 and T3) of IL-6. CONCLUSION: AVR through upper ministernotomy was associated with a significant increase in postoperative plasma levels of mtDNA and cytokines. There was no difference in the mtDNA levels between the sutureless and conventional valve groups, suggesting a similar level of inflammation in both groups. However, the shorter operation time observed in the sutureless valve group was associated with significantly lower postoperative levels of IL-6, indicating potential clinical benefits.

Abordaje mínimamente invasivo para la asistencia biventricular con bombas centrífugas: primera experiencia en España / Minimally invasive approach for biventricular assist device with centrifugal pump: first experience in Spain

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Galectina-3 circulante tras el trasplante cardiaco: dinámica a largo plazo y valor pronóstico / Circulating galectin-3 following heart transplant: long-term dynamics and prognostic value

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

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

Valve-Sparing Tetralogy of Fallot Repair With Intraoperative Dilation of the Pulmonary Valve. Mid-Term Results.

Deleterious long-term effects of chronic pulmonary regurgitation after repair of tetralogy of Fallot have become evident during the last decades. Subsequently, some groups have developed strategies to spare the pulmonary valve function at the time of repair with good early results. However, mid-term outcomes are scarce in the literature and in some cases controversial. The aim of our study is to report our results mid-term with valve-sparing repair of tetralogy of Fallot. We retrospectively reviewed patients undergoing tetralogy of Fallot repair and having preservation of the pulmonary valve with intraoperative dilation at our institution. From June 2009 through June 2017, 42 patients underwent valve-sparing tetralogy of Fallot repair. Median age and weight at surgery were 5.2 months and 7.2 kg. Median preoperative pulmonary valve diameters and Z scores by echocardiography were 6.4 mm (range 4.5-11 mm) and -2.3 (range -1.3 to -4.5). No patient died in our series. For a median follow-up of 45 months, the pulmonary valve has grown by Z score (P < 0.0001) as well as the pulmonary trunk (P= 0.00216). Significant pulmonary regurgitation has developed in 9 patients (21.4%). No patient has required reintervention/reoperation for recurrent right ventricular outflow tract obstruction. Patients with tetralogy of Fallot who had valve-sparing repair with intraoperative dilation of the pulmonary valve show good early and mid-term results with respect to right ventricular outflow tract obstruction. The pulmonary valve annulus and the pulmonary trunk grow through follow-up. Progressive development of significant pulmonary regurgitation is seen in more than 20% of patients. Long-term data with this approach and comparison with a population of patients undergoing a transannular patch repair are required to establish the real utility of this approach.

Tratamiento de la obstrucción del tracto de salida en la miocardiopatía hipertrófica mediante reparación mitral: «miectomía sin miectomía» / Mitral repair as a treatment of outflow tract obstruction in hypertrophic cardiomyopathy: "myectomy without myectomy"

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Mitochondrial DNA haplogroups influence the risk of aortic stenosis.

AIM: The underlying pathophysiologic mechanisms of aortic stenosis are not clear. Mitochondrial dysfunction plays a role in many pathological conditions including cardiac diseases. We aimed to analyze the mitochondrial DNA haplogroups in a group of patients undergoing valve replacement surgery due to severe aortic stenosis. METHODS: Mitochondrial DNA haplogroups were assessed in 176 patients with severe aortic stenosis and 308 control subjects. Cardiovascular risk factors and demographics were similar in both groups. RESULTS: Patients carrying haplogroup Uk had a lower risk of developing aortic stenosis, especially compared to patients carrying haplogroup H (odds ratio = 0.507; 95% confidence interval: 0.270-0.952, p = 0.035). CONCLUSIONS: Mitochondrial DNA haplogroups could be involved in the development of severe aortic stenosis. Specifically, haplogroup H could be a risk factor and Uk a protective factor for severe aortic stenosis in a population from Spain.

Circulating Galectin-3 Following Heart Transplant: Long-term Dynamics and Prognostic Value.

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.

Efficacy and safety of transcatheter valve-in-valve replacement for Mitroflow bioprosthetic valve dysfunction.

OBJECTIVES: Bioprostheses with pericardial leaflets mounted externally on the stent pose a high risk for valve-in-valve (ViV) procedures. This study analyzed the efficacy and safety of ViV procedures for treating structural valve deterioration (SVD) in Mitroflow bioprostheses. METHODS: Between January 2012 and August 2017, 11 patients (mean age 80.3 ± 5.6 years) were treated for SVD of Mitroflow bioprostheses with transcatheter ViV procedures (six transapical [TA] and five transfemoral [TF]) using balloon expandable bioprostheses. RESULTS: All patients but one were in NYHA class III-IV. Mean STS PROM, euroSCORE I, and euroSCORE II were 8 ± 6.5%, 27.8 ± 11.5%, and 12 ± 5.9%, respectively. Two patients had a "porcelain aorta." The size of implanted valves were 23 mm in 10 cases and 26 mm in one case. One patient suffered a coronary occlusion during a TF approach. The mean volume of contrast used in TF implants was 163 ± 69.8 mL. No contrast media were used in TA procedures. There was one in-hospital death (10%). At 1 year of follow-up, peak and mean aortic gradients were 25.5 ± 5.8 mmHg and 15.5 ± 5.7 mmHg, respectively. One patient had mild paravalvular regurgitation. Cumulative survival was 90.9% at 1 year, 70.7% at 2 years, and 53% at 3 years. CONCLUSIONS: ViV procedures with balloon-expandable aortic valves provide good hemodynamic and clinical mid-term results for treating patients with a degenerated Mitroflow aortic bioprosthesis. Special care must be taken in small aortic roots, when the stented valve is in the supra-annular position to avoid coronary ostial obstruction.

Late graft failure in heart transplant recipients: incidence, risk factors and clinical outcomes.

AIM: To analyse the incidence, risk factors and clinical outcomes of late graft failure after heart transplantation. METHODS AND RESULTS: We conducted an observational, single-centre study based on 547 patients who underwent cardiac transplantation from 1991 to 2014 and who survived the in-hospital postoperative period. Late graft failure was defined as the first hospitalization due to this condition after discharge. Over a mean follow-up of 8.4 ± 6 years, 178 (32.5%) patients were hospitalized due to late graft failure [incidence rate: 3.6 cases per 100 patient-years, 95% confidence interval (CI) 3.1-4.2]. Pre-transplant diabetes, higher pre-transplant transpulmonary pressure gradient and lower donor-recipient weight ratio were independently associated with higher risk of graft failure. Cardiac allograft vasculopathy, cellular rejection grade ≥1R, and antibody-mediated rejection grade ≥1 were detected in 50.6%, 44.9% and 19.2% patients, respectively, admitted due to graft failure. Left ventricular ejection fraction was ≥50% in 60.1% of these patients. Re-transplant free survival 1, 5, 10 and 15 years after the diagnosis of late graft failure was 72.2%, 38.4%, 18.4%, and 7.5%, respectively; the incidence rate of re-hospitalization due to decompensated heart failure was 40.9 episodes per 100 patient-years (95% CI 36.6-46.1). The need for inotropes, the presence of cardiac allograft vasculopathy, higher creatinine serum levels, lower ejection fraction and lower sodium serum levels were independent predictors of worse outcomes. CONCLUSIONS: Late graft failure is frequent after heart transplantation, as it is associated with poor outcomes. Rejection and cardiac allograft vasculopathy are the most frequent underlying causes.

Rationale and design of a multicentre, prospective, randomised, controlled clinical trial to evaluate the efficacy of the adipose graft transposition procedure in patients with a myocardial scar: the AGTP II trial.

INTRODUCTION: Cardiac adipose tissue is a source of progenitor cells with regenerative capacity. Studies in rodents demonstrated that the intramyocardial delivery of cells derived from this tissue improves cardiac function after myocardial infarction (MI). We developed a new reparative approach for damaged myocardium that integrates the regenerative properties of cardiac adipose tissue with tissue engineering. In the adipose graft transposition procedure (AGTP), we dissect a vascularised flap of autologous pericardial adipose tissue and position it over the myocardial scarred area. Following encouraging results in acute and chronic MI porcine models, we performed the clinical trial (NCT01473433, AdiFLAP trial) to evaluate safety in patients with chronic MI undergoing coronary artery bypass graft. The good safety profile and trends in efficacy warranted a larger trial. STUDY DESIGN: The AGTP II trial (NCT02798276) is an investigator initiated, prospective, randomised, controlled, multicentre study to assess the efficacy of the AGTP in 108 patients with non-revascularisable MI. Patients will be assigned to standard clinical practice or the AGTP. The primary endpoint is change in necrotic mass ratio by gadolinium enhancement at 91 and 365 days. Secondary endpoints include improvement in regional contractibility by MRI at 91 and 365 days; changes in functional MRI parameters (left ventricular ejection fraction, left and right ventricular geometric remodelling) at 91 and 365 days; levels of N-terminal prohormone of brain natriuretic peptide (NT-proBNP) at 7, 91 and 365 days; appearance of arrhythmias from 24 hour Holter monitoring at 24 hours, and at 91 and 365 days; all cause death or re-hospitalisation at 365 days; and cardiovascular death or re-hospitalisation at 365 days. ETHICS AND DISSEMINATION: The institutional review board approved the trial which will comply with the Declaration of Helsinki. All patients will provide informed consent. It may offer a novel, effective and technically simple technique for patients with no other therapeutic options. The results will be submitted to indexed medical journals and national and international meetings. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov: NCT02798276, pre-results.

Valor pronóstico del índice de riesgo nutricional en receptores de trasplante cardiaco / Prognostic value of the nutritional risk index in heart transplant recipients

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 (AU)

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 (AU)

Indexed left atrial size predicts all-cause and cardiovascular mortality in patients undergoing aortic valve surgery.

OBJECTIVES: The enlargement of the left atrium has been identified as a marker of chronically increased left ventricular filling pressure and left ventricular diastolic dysfunction. This study aims to evaluate the association of indexed left atrial diameter with stroke, cardiovascular mortality, the combined event, and all-cause mortality in patients who underwent aortic valve surgery. METHODS: Indexed left atrial diameter was measured in 2011 adult patients (mean age, 70.9 ± 10.8 years; 58.7% were men) who underwent aortic valve surgery between January 2008 and March 2016. RESULTS: On the basis of the criteria of the American Society of Echocardiography, indexed left atrial diameter was normal in 64% of patients, mildly enlarged in 12.4% of patients, moderately enlarged in 9.2% of patients, and severely enlarged in 14.3% of patients. Over a mean follow-up period of 3.2 ± 2.1 years, there were 334 deaths and 97 strokes. Cardiovascular mortality survival at 5 years among patients with normal, mild, moderate, and severe left atrial enlargement was 91.6%, 86.8%, 77.9%, and 77.4%, respectively (P < .001). After covariable adjustment, Cox regression analysis showed indexed left atrial diameter as an independent predictor of all-cause mortality (hazard ratio per 1-cm/m2 increment, 1.545; 95% confidence interval, 1.252-1.906, P < .001), cardiovascular death (hazard ratio per 1-cm/m2 increment, 1.971; 95% confidence interval, 1.541-2.520; P < .001), and the combined event (hazard ratio per 1-cm/m2 increment, 1.673; 95% confidence interval, 1.321-2.119; P < .001). CONCLUSIONS: Indexed left atrial diameter is a strong predictor of long-term outcomes in patients with aortic valve diseases who undergo surgery.

Prognostic Value of the Nutritional Risk Index in Heart Transplant Recipients.

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.

Rapid Deployment Aortic Replacement (RADAR) Registry in Spain: a protocol.

INTRODUCTION: Rapid deployment valves (RDV) represent a newly introduced approach to aortic valve replacement which facilitates surgical implantation and minimally invasive techniques, shortens surgical times and shows excellent haemodynamic performance. However, evidence on their safety, efficacy and potential complications is mostly fitted with small-volume and retrospective studies. Moreover, no current guidelines exist. To improve our knowledge on this technology, The Rapid Deployment Aortic Replacement (RADAR) Registry will be established across Spain with the aim of assessing RDV outcomes in the real-world setting. METHODS AND ANALYSIS: The RADAR Registry is designed as a product registry that would provide information on its use and outcomes in clinical practice. This multicentre, prospective, national effort will initially involve 4 centres in Spain. Any patient undergoing cardiac surgery for aortic valve replacement and receiving an RDV as an isolated operation or in combination with other cardiac procedures may be included. Participation is voluntary. Data collection is equal to information obtained during standard care and is prospectively entered by the participating physicians perioperatively and during subsequent follow-up visits. The primary outcome assessed is in-hospital and up to 5 years of follow-up, prosthetic valve functioning and clinical status. Secondary outcomes are to perform subgroup analysis, to compare outcomes with other existing approaches and to develop future clinical guidelines. The follow-up assessments are timed with routine clinical appointments. Dissociated data will be extracted and collectively analysed. Initial target sample size for the registry is 500 participants entered with complete follow-up information. Different substudies will be implemented within the registry to investigate specific populations undergoing aortic valve replacement. ETHICS AND DISSEMINATION: The protocol is approved by all local institutional ethics committees. Findings will be shared by the participant hospitals, policymakers and the academic community to promote quality monitoring and efficient use of this technology.

Estado serológico frente a Toxoplasma gondii en receptores de trasplante cardiaco: ¿un factor pronóstico independiente? / Toxoplasma gondii serostatus in heart transplant recipients: is it an independent prognostic factor?

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 (AU)

Introduction and objectives: To assess the potential association between recipient Toxoplasma gondii serostatus and outcomes after heart transplant (HT). Methods: We conducted a retrospective single-center study of 657 HT recipients from 1991 to 2015. Survival and the incidence of adverse clinical events of T. gondii-seropositive (n = 481) vs T. gondii-seronegative (n = 176) recipients were compared by means of 2 different multivariable Cox regression models. Model 1 included solely age and sex, and model 2 included other potential confounders. Results: Over a median follow-up of 2903 days (interquartile range: 898-4757), 250 seropositive recipients (52%) and 72 seronegative recipients (41%) died. Univariable analysis showed increased posttransplant mortality among T. gondii-seropositive recipients (hazard ratio [HR] = 1.31; 95% confidence interval [95%CI], 1,00-1.70). After multivariable adjustment, the statistical significance of this association was lost (model 1: HR = 1.09; 95%CI, 0.83-1.43; model 2:HR = 1.12; 95%CI, 0.85-1.47). Recipient T. gondii seropositivity was independently associated with an increased risk of acute rejection (model 1: HR = 1.36; 95%CI, 1.06-1.74; model 2: HR = 1.29; 95%CI, 1.01-1.66). Multivariable models showed no statistically significant impact of recipient T. gondii serostatus on the incidence of infection, malignancy, coronary allograft vasculopathy, or the composite outcome of cardiac death or retransplant. No significant association was found between donor-recipient T. gondii serostatus matching and posttransplant outcome. Conclusions: In this study, recipient T. gondii serostatus was not an independent predictor of long-term post-HT outcome (AU)