Sildenafil for improving outcomes in patients with corrected valvular heart disease and persistent pulmonary hypertension: a multicenter, double-blind, randomized clinical trial.

Aims: We aimed to determine whether treatment with sildenafil improves outcomes of patients with persistent pulmonary hypertension (PH) after correction of valvular heart disease (VHD). Methods and results: The sildenafil for improving outcomes after valvular correction (SIOVAC) study was a multricentric, randomized, parallel, and placebo-controlled trial that enrolled stable adults with mean pulmonary artery pressure ≥ 30 mmHg who had undergone a successful valve replacement or repair procedure at least 1 year before inclusion. We assigned 200 patients to receive sildenafil (40 mg three times daily, n = 104) or placebo (n = 96) for 6 months. The primary endpoint was the composite clinical score combining death, hospital admission for heart failure (HF), change in functional class, and patient global self-assessment. Only 27 patients receiving sildenafil improved their composite clinical score, as compared with 44 patients receiving placebo; in contrast 33 patients in the sildenafil group worsened their composite score, as compared with 14 in the placebo group [odds ratio 0.39; 95% confidence interval (CI) 0.22-0.67; P < 0.001]. The Kaplan-Meier estimates for survival without admission due to HF were 0.76 and 0.86 in the sildenafil and placebo groups, respectively (hazard ratio 2.0, 95% CI = 1.0-4.0; log-rank P = 0.044). Changes in 6-min walk test distance, natriuretic peptides, and Doppler-derived systolic pulmonary pressure were similar in both groups. Conclusion: Treatment with sildenafil in patients with persistent PH after successfully corrected VHD is associated to worse clinical outcomes than placebo. Off-label usage of sildenafil for treating this source of left heart disease PH should be avoided. The trial is registered with ClinicalTrials.gov, number NCT00862043.

Pravastatin improves endothelial function in arteries used in coronary bypass grafting.

Internal mammary artery (IMA) and radial artery (RA) are the 2 main arterial conduits used in coronary artery bypass grafting (CABG). The aim of this study was to analyze in vitro the vasoreactive properties in both vessels and to investigate the effects of pravastatin incubation on vascular function. IMA and RA rings obtained from patients undergoing CABG were studied in organ baths. We examined the contractile responses to phenylephrine and U46619 and the relaxation to acetylcholine (ACh) and sodium nitroprusside. In another series of experiments, the vascular reactivity and the superoxide anion production were studied after incubation with pravastatin. The effect of mevalonic acid on such responses was also assessed. Our results show that RA significantly evoked greater tension in response to vasoconstrictor agents and higher relaxation to ACh than IMA. In contrast, relaxation induced by sodium nitroprusside was not significantly different. Incubation with pravastatin reduced the contractile response to U46619 and improved the endothelium-dependent relaxation to ACh in both arteries. Whereas the effect of pravastatin on response to U46619 was completely abolished by coincubation with mevalonic acid, only a partial inhibition on ACh relaxation was observed. In conclusion, in vitro incubation with pravastatin enhanced endothelial function in IMA and RA. This suggests that postoperative (may include intraoperative) administration of statins could improve the endothelial function of arterial grafts in patients undergoing CABG.

Clinical outcomes and quality of life after contemporary isolated coronary bypass grafting: a prospective cohort study.

OBJECTIVES: The objective of the European Multicenter Registry to Assess Outcomes in coronary artery bypass grafting (CABG) patients (DuraGraft Registry) was to determine clinical outcomes and quality of life (QoL) after contemporary CABG that included isolated CABG and combined CABG/valve procedures, using an endothelial damage inhibitor (DuraGraft) intraoperatively for conduit preservation. Here, we report outcomes in the patient cohort undergoing isolated CABG. METHODS: The primary outcome was the composite of all-cause death, myocardial infarction (MI), or repeat revascularization (RR) [major adverse cardiac events (MACE)] at 1 year. Secondary outcomes included the composite of all-cause death, MI, RR, or stroke [major adverse cardiac and cerebrovascular events (MACCE)], and QoL. QoL was assessed with the EuroQol-5 Dimension questionnaire. Independent risk factors for MACE at 1 year were determined using Cox regression analysis. RESULTS: A total of 2532 patients (mean age, 67.4±9.2 years; 82.5% male) underwent isolated CABG. The median EuroScore II was 1.4 [interquartile range (IQR), 0.9-2.3]. MACE and MACCE rates at 1 year were 6.6% and 7.8%, respectively. The rates of all-cause death, MI, RR, and stroke were 4.4, 2.0, 2.2, and 1.9%, respectively. The 30-day mortality rate was 2.3%. Age, extracardiac arteriopathy, left ventricular ejection fraction less than 50%, critical operative state, and left main disease were independent risk factors for MACE. QoL index values improved from 0.84 [IQR, 0.72-0.92] at baseline to 0.92 [IQR, 0.82-1.00] at 1 year ( P <0.0001). CONCLUSION: Contemporary European patients undergoing isolated CABG have a low 1-year clinical event rate and an improved QoL.

Clinical event rate in patients with and without left main disease undergoing isolated coronary artery bypass grafting: results from the European DuraGraft Registry.

OBJECTIVES: Left main coronary artery disease (LMCAD) is considered an independent risk factor for clinical events after coronary artery bypass grafting (CABG). We have conducted a subgroup analysis of the multicentre European DuraGraft Registry to investigate clinical event rates at 1 year in patients with and without LMCAD undergoing isolated CABG in contemporary practice. METHODS: Patients undergoing isolated CABG were selected. The primary end point was the incidence of a major adverse cardiac event (MACE) defined as the composite of death, myocardial infarction (MI) or repeat revascularization (RR) at 1 year. The secondary end point was major adverse cardiac and cerebrovascular events (MACCE) defined as MACE plus stroke. Propensity score matching was performed to balance for differences in baseline characteristics. RESULTS: LMCAD was present in 1033 (41.2%) and absent in 1477 (58.8%) patients. At 1 year, the MACE rate was higher for LMCAD patients (8.2% vs 5.1%, P = 0.002) driven by higher rates of death (5.4% vs 3.4%, P = 0.016), MI (3.0% vs 1.3%, P = 0.002) and numerically higher rates of RR (2.8% vs 1.8%, P = 0.13). The incidence of MACCE was 8.8% vs 6.6%, P = 0.043, with a stroke rate of 1.0% and 2.4%, P = 0.011, for the LMCAD and non-LMCAD groups, respectively. After propensity score matching, the MACE rate was 8.0% vs 5.2%, P = 0.015. The incidence of death was 5.1% vs 3.7%, P = 0.10, MI 3.0% vs 1.4%, P = 0.020, and RR was 2.7% vs 1.6%, P = 0.090, for the LMCAD and non-LMCAD groups, respectively. Less strokes occurred in LMCAD patients (1.0% vs 2.4%, P = 0.017). The MACCE rate was not different, 8.5% vs 6.7%, P = 0.12. CONCLUSIONS: In this large registry, LMCAD was demonstrated to be an independent risk factor for MACE after isolated CABG. Conversely, the risk of stroke was lower in LMCAD patients. CLINICAL TRIAL REGISTRATION NUMBER: ClinicalTrials.gov NCT02922088.

Persistent Pulmonary Hypertension in Corrected Valvular Heart Disease: Hemodynamic Insights and Long-Term Survival.

Background The determinants and consequences of pulmonary hypertension after successfully corrected valvular heart disease remain poorly understood. We aim to clarify the hemodynamic bases and risk factors for mortality in patients with this condition. Methods and Results We analyzed long-term follow-up data of 222 patients with pulmonary hypertension and valvular heart disease successfully corrected at least 1 year before enrollment who had undergone comprehensive hemodynamic and imaging characterization as per the SIOVAC (Sildenafil for Improving Outcomes After Valvular Correction) clinical trial. Median (interquartile range) mean pulmonary pressure was 37 mm Hg (32-44 mm Hg) and pulmonary artery wedge pressure was 23 mm Hg (18-26 mm Hg). Most patients were classified either as having combined precapillary and postcapillary or isolated postcapillary pulmonary hypertension. After a median follow-up of 4.5 years, 91 deaths accounted for 4.21 higher-than-expected mortality in the age-matched population. Risk factors for mortality were male sex, older age, diabetes mellitus, World Health Organization functional class III and higher pulmonary vascular resistance-either measured by catheterization or approximated from ultrasound data. Higher pulmonary vascular resistance was related to diabetes mellitus and smaller residual aortic and mitral valve areas. In turn, the latter correlated with prosthetic nominal size. Six-month changes in the composite clinical score and in the 6-minute walk test distance were related to survival. Conclusions Persistent valvular heart disease-pulmonary hypertension is an ominous disease that is almost universally associated with elevated pulmonary artery wedge pressure. Pulmonary vascular resistance is a major determinant of mortality in this condition and is related to diabetes mellitus and the residual effective area of the corrected valve. These findings have important implications for individualizing valve correction procedures. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT00862043.

Left Ventricular Assist Device Therapy for Destination Therapy: Is Less Invasive Surgery a Safe Alternative?

INTRODUCTION AND OBJECTIVES: The number of older patients with congestive heart failure has dramatically increased. Because of stagnating cardiac transplantation, there is a need for an alternative therapy, which would solve the problem of insufficient donor organ supply. Left ventricular assist devices (LVADs) have recently become more commonly used as destination therapy (DT). Assuming that older patients show a higher risk-profile for LVAD surgery, it is expected that the increasing use of less invasive surgery (LIS) LVAD implantation will improve postoperative outcomes. Thus, this study aimed to assess the outcomes of LIS-LVAD implantation in DT patients. METHODS: We performed a prospective analysis of 2-year outcomes in 46 consecutive end-stage heart failure patients older than 60 years, who underwent LVAD implantation (HVAD, HeartWare) for DT in our institution between 2011 and 2013. The patients were divided into 2 groups according to the surgical implantation technique: LIS (n = 20) vs conventional (n = 26). RESULTS: There was no statistically significant difference in 2-year survival rates between the 2 groups, but the LIS group showed a tendency to improved patient outcome in 85.0% vs 69.2% (P = .302). Moreover, the incidence of postoperative bleeding was minor in LIS patients (0% in the LIS group vs 26.9% in the conventional surgery group, P < .05), who also showed lower rates of postoperative extended inotropic support (15.0% in the LIS group vs 46.2% in the conventional surgery group, P < .05). CONCLUSIONS: Our data indicate that DT patients with LIS-LVAD implantation showed a lower incidence of postoperative bleeding, a reduced need for inotropic support, and a tendency to lower mortality compared with patients treated with the conventional surgical technique.

[Arterial grafts in coronary surgery. Treatment for everyone?]. / Los injertos arteriales en cirugía coronaria: una terapia universal?

At present, arterial conduits are the key elements of coronary bypass surgery. The clear benefits of using the left internal mammary artery for revascularization of the left anterior descending coronary artery have encouraged the use of other arteries in different areas. The right internal mammary artery and the radial artery are competing for the role as the second most useful conduit. Moreover, use of the right gastroepiploic artery or the inferior epigastric artery, although both are less popular, enables complete revascularization to be carried out using only arterial grafts in most patients. The majority of publications on the subject endorse the extensive use of arterial conduits. However, most findings are based on observational and angiographic data that are derived essentially from studies on symptomatic patients. Consequently, indications for the different techniques have not been standardized. On the other hand, the patency of saphenous vein grafts has improved recently. This article describes the anatomical and histologic characteristics of arterial conduits. The indications for, and advantages and limitations of, the different techniques available are reviewed. In addition, the clinical and angiographic results achieved are considered, as is the role of arterial conduits in different anatomical and clinical settings. Finally, the future application of this type of surgery is discussed.

[Coronary artery surgery in diabetic patients]. / Cirugía de revascularización coronaria en el paciente diabético.

Currently, 15% to 30% of the patients that undergo coronary artery surgery are diabetics. As a group, they have less favorable anatomic and clinical characteristics than the general population. Specifically, diabetics have more extensive coronary disease, more vessels involved, and more diffuse stenosis, so they need a higher number of distal anastomoses to achieve complete revascularization. In spite of these drawbacks, they can undergo coronary artery bypass procedures with an operative mortality similar to that of non-diabetic patients. However, some postoperative complications are significantly more prevalent among diabetics, mainly renal failure, neurological accidents, sternal dehiscence, and infection. In early studies of the late results of surgical revascularization, mainly based on venous grafts, late survival and clinical improvement were less satisfactory in diabetics than in non-diabetics. However, in recent experiences, in which the internal mammary artery has been used extensively, the clinical outcome of diabetics has been similar to that of non-diabetics, confirming this procedure as the preferred one in revascularizing the coronary arteries of diabetics with multivessel disease. Off-pump surgery and extensive use of arterial grafts are becoming established strategies for reducing operative risk and improving long-term clinical results. However, continuous, strict medical management of hyperglycemia and other known coronary risk factors, especially lipid levels, is essential.

Asistencia ventricular izquierda como terapia de destino: ¿la cirugía mínimamente invasiva es una alternativa segura? / Left ventricular assist device therapy for destination therapy: is less invasive surgery a safe alternative?

Introducción y objetivos: El número de pacientes ancianos con insuficiencia cardiaca terminal ha crecido espectacularmente. Considerando que el número de trasplantes cardiacos se ha estancado, se requiere una alternativa terapéutica. Desde hace poco se están aplicando como terapia de destino (TD) dispositivos de asistencia ventricular izquierda (DAVI). Asumiendo que los pacientes de más edad tienen mayor riesgo quirúrgico, es presumible que la cirugía menos invasiva (CMI) para el DAVI contribuya a mejorar los resultados operatorios en pacientes en TD. Métodos: Se realizó un estudio prospectivo con un seguimiento de 2 años de 46 pacientes en TD (edad mayor de 60 años) consecutivos a los que se trató con DAVI (HVAD, HeartWare) en nuestra institución entre 2011 y 2013. Se formaron 2 grupos según el método quirúrgico de implante: CMI (n = 20) o cirugía convencional (n = 26). Resultados: A pesar de que no se hallaron diferencias estadísticas significativas respecto a la supervivencia a 2 años, sí se observó una tendencia a mayor supervivencia en el grupo CMI (el 85,0 frente al 69,2%; p = 0,302). Asimismo, los pacientes del grupo de CMI presentaron menor incidencia de hemorragias tras la cirugía (0 frente al 26,9%; p < 0,05), junto con menores tasas de uso prolongado de inotrópicos tras la cirugía (el 15,0 frente al 46,2%; p < 0,05). Conclusiones: Los datos indican que los pacientes sometidos a CMI para implante de DAVI como TD muestran tras la cirugía menor incidencia de hemorragias, menor necesidad de apoyo con inotrópicos y una tendencia a menor mortalidad que los pacientes operados de manera convencional (AU)

Introduction and objectives: The number of older patients with congestive heart failure has dramatically increased. Because of stagnating cardiac transplantation, there is a need for an alternative therapy, which would solve the problem of insufficient donor organ supply. Left ventricular assist devices (LVADs) have recently become more commonly used as destination therapy (DT). Assuming that older patients show a higher risk-profile for LVAD surgery, it is expected that the increasing use of less invasive surgery (LIS) LVAD implantation will improve postoperative outcomes. Thus, this study aimed to assess the outcomes of LIS-LVAD implantation in DT patients. Methods: We performed a prospective analysis of 2-year outcomes in 46 consecutive end-stage heart failure patients older than 60 years, who underwent LVAD implantation (HVAD, HeartWare) for DT in our institution between 2011 and 2013. The patients were divided into 2 groups according to the surgical implantation technique: LIS (n = 20) vs conventional (n = 26). Results: There was no statistically significant difference in 2-year survival rates between the 2 groups, but the LIS group showed a tendency to improved patient outcome in 85.0% vs 69.2% (P = .302). Moreover, the incidence of postoperative bleeding was minor in LIS patients (0% in the LIS group vs 26.9% in the conventional surgery group, P < .05), who also showed lower rates of postoperative extended inotropic support (15.0% in the LIS group vs 46.2% in the conventional surgery group, P < .05). Conclusions: Our data indicate that DT patients with LIS-LVAD implantation showed a lower incidence of postoperative bleeding, a reduced need for inotropic support, and a tendency to lower mortality compared with patients treated with the conventional surgical technique (AU)

Evaluación integral de asistencia ventricular Heartware HVAD mediante tomografía computarizada cardiaca en cuatro dimensiones / Comprehensive assessment of the heartware HVAD left ventricular assist device with 4-dimensional cardiac computed tomography

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Dispositivos de asistencia ventricular izquierda de larga duración en centros no trasplantadores en España: experiencia inicial / Durable left ventricular assist device therapy in non transplant centers in Spain: initial experience

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[Cardiac surgery in the elderly: comparison of medium-term clinical outcomes in octogenarians and the elderly from 75 to 79 years]. / Cirugía cardiaca en el anciano: comparación de resultados a medio plazo entre octogenarios y ancianos de 75 a 79 años.

INTRODUCTION AND OBJECTIVES: The age of patients undergoing cardiac surgery has increased in recent years. Our aims were to investigate the medium-term clinical outcomes of surgery in octogenarians and to compare them with outcomes in other elderly individuals of a less advanced age. METHODS: We investigated early mortality, the incidence of postoperative complications, medium-term survival and factors associated with these parameters in 589 consecutive elderly patients undergoing surgery: 140 were octogenarians aged 80-87 years (group I) while 449 were aged between 75 and 79 years (group II). RESULTS: The two groups were similar. There was no difference in mortality (10.0% in group I vs. 10.9% in group II) or in the incidence of postoperative complications (22% in group I vs. 30% in group II). Emergency surgery, combined surgery and pulmonary hypertension were all independent predictors of mortality and of major postoperative complications. The 5-year survival rate was 79% in group I and 65% in group II (P=.832) and the cardiac event-free survival rate was 75% in group I and 64% in group II (P=.959). Overall, 97% of patients in both groups were in functional class I or II. The additive EuroSCORE and preoperative atrial fibrillation were both associated with increased mortality during follow-up. Being an octogenarian was not a predictor (hazard ratio=0.78; 95% confidence interval, 0.51-1.21; P=.373). CONCLUSIONS: In selected octogenarians, cardiac surgery gives similar results to those obtained in other elderly individuals of a less advanced age. The medium-term survival rate and quality of life are good. Pulmonary hypertension, emergency surgery and combined surgery all increased risk in these patients.

Cirugía cardiaca en el anciano: comparación de resultados a medio plazo entre octogenarios y ancianos de 75 a 79 años / Cardiac Surgery in the Elderly: Comparison of Medium-Term Clinical Outcomes in Octogenarians and the Elderly From 75 to 79 Years

Introducción y objetivos. La edad de los pacientessometidos a cirugía cardiaca se ha incrementado en losúltimos años. Pretendemos conocer los resultados a medioplazo de la cirugía en octogenarios, comparándoloscon los de otros ancianos de menos edad.Métodos. Analizamos la mortalidad precoz, la incidenciade complicaciones postoperatorias, la supervivencia amedio plazo y los factores asociados a éstas de 589 ancianos consecutivos sometidos a cirugía: 140 octogenarios entre 80 y 87 años (grupo I) y 449 entre 75 y 70 años (grupo II).Resultados. Ambos grupos fueron homogéneos. Nohubo diferencias en la mortalidad (I, 10%; II, 10,9%) e incidencia de complicaciones postoperatorias (I, 22%; II,30%). La cirugía de emergencia, la combinada y la hipertensión pulmonar se asociaron de manera independiente a la mortalidad y al desarrollo de complicaciones mayores. La supervivencia a 5 años fue del 79% (I) y el 65% (II) (p = 0,832) y la supervivencia libre de evento cardiaco fue del 75% (I) y el 64% (II) respectivamente (p = 0,959). El 97% de los pacientes de ambos grupos se encontraban en clase funcional I-II. El EuroSCORE aditivo y la fibrilaciónauricular preoperatoria se asociaron a una mayormortalidad en el seguimiento. Ser octogenario no fuepredictor (hazard ratio = 0,78; intervalo de confianza del 95%, 0,51-1,21; p = 0,373).Conclusiones. La cirugía cardiaca en octogenarios seleccionados ofrece resultados similares a los de otros ancianos más jóvenes, con una buena supervivencia y calidad de vida a medio plazo. La hipertensión pulmonar, la cirugía de emergencia y la combinada conllevan un riesgo elevado en estos pacientes

Introduction and objectives. The age of patientsundergoing cardiac surgery has increased in recentyears. Our aims were to investigate the medium-termclinical outcomes of surgery in octogenarians and tocompare them with outcomes in other elderly individualsof a less advanced age.Methods. We investigated early mortality, the incidenceof postoperative complications, medium-term survival andfactors associated with these parameters in 589consecutive elderly patients undergoing surgery: 140were octogenarians aged 80-87 years (group I) while 449were aged between 75 and 79 years (group II).Results. The two groups were similar. There was nodifference in mortality (10.0% in group I vs. 10.9% in group II) or in the incidence of postoperative complications (22% in group I vs. 30% in group II). Emergency surgery, combined surgery and pulmonary hypertension were all independent predictors of mortality and of major postoperative complications. The 5-year survival rate was 79% in group I and 65% in group II (P=.832) and the cardiac event-free survival rate was 75% in group I and 64% in group II (P=.959). Overall, 97% of patients in both groups were in functional class I or II. The additive EuroSCORE and preoperative atrial fibrillation were both associated with increased mortality during follow-up. Being an octogenarian was not a predictor (hazard ratio=0.78; 95% confidence interval, 0.51—1.21; P=.373).Conclusions. In selected octogenarians, cardiacsurgery gives similar results to those obtained in otherelderly individuals of a less advanced age. The mediumterm survival rate and quality of life are good. Pulmonary hypertension, emergency surgery and combined surgery all increased risk in these patients

¿Gestión pública o gestión privada? Implicaciones en los resultados de la cirugía coronaria / Does nature of hospital financing influence early mortality after coronary artery bypass grafting

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Los injertos arteriales en cirugía coronaria: ¿una terapia universal? / Arterial grafts in coronary surgery. Treatment for everyone?

Los conductos arteriales son, hoy día, elementos fundamentales de la cirugía coronaria. Las indiscutibles ventajas de la revascularización de la descendente anterior con la arteria mamaria izquierda han impulsado la utilización de otras arterias en territorios diferentes. La arteria mamaria derecha y la arteria radial se disputan el papel de segundo conducto. Además, la arteria gastroepiploica derecha y la epigástrica inferior, aunque menos populares, permiten conseguir una revascularización completa utilizando exclusivamente injertos arteriales en la mayoría de los pacientes. La mayoría de las publicaciones al respecto avalan el uso extensivo de los conductos arteriales. Sin embargo, gran parte de esta información está basada en estudios observacionales y los datos angiográficos se refieren fundamentalmente a pacientes sintomáticos, por lo que las indicaciones de las diferentes técnicas no están estandarizadas. Por otra parte, la permeabilidad de los injertos de vena safena en nuestros días ha mejorado con respecto a la de épocas anteriores. En este artículo se describen las características anatómicas e histológicas de los conductos arteriales. Se comentan las diferentes opciones técnicas con sus indicaciones, ventajas e inconvenientes. También se analizan los resultados, tanto clínicos como angiográficos, y el papel de los injertos arteriales en los distintos escenarios anatómicos y clínicos. Por último, se discuten las perspectivas futuras de este tipo de cirugía

At present, arterial conduits are the key elements of coronary bypass surgery. The clear benefits of using the left internal mammary artery for revascularization of the left anterior descending coronary artery have encouraged the use of other arteries in different areas. The right internal mammary artery and the radial artery are competing for the role as the second most useful conduit. Moreover, use of the right gastroepiploic artery or the inferior epigastric artery, although both are less popular, enables complete revascularization to be carried out using only arterial grafts in most patients. The majority of publications on the subject endorse the extensive use of arterial conduits. However, most findings are based on observational and angiographic data that are derived essentially from studies on symptomatic patients. Consequently, indications for the different techniques have not been standardized. On the other hand, the patency of saphenous vein grafts has improved recently. This article describes the anatomical and histologic characteristics of arterial conduits. The indications for, and advantages and limitations of, the different techniques available are reviewed. In addition, the clinical and angiographic results achieved are considered, as is the role of arterial conduits in different anatomical and clinical settings. Finally, the future application of this type of surgery is discussed