Resultados a muy largo plazo tras la implantación de stents liberadores de fármacos en la estenosis de arteria coronaria principal izquierda no protegida: experiencia de un centro

Introduction and objectives

Encouraging results at long-term follow-up have been reported from non-randomized registries and randomized trials following percutaneous coronary intervention with drug-eluting stent implantation for unprotected left main stenosis. However, information on very long-term (>5-year) outcomes is limited. The aim of this study was to assess the very long-term outcomes (6-years) following drug-eluting stent implantation for left main disease.

Methods

All consecutive patients with unprotected left main stenosis electively treated with drug-eluting stent implantation, between March 2002 and May 2005, were analyzed according to the location of the left main lesion (distal bifurcation vs ostial/body).

Results

The study included 149 patients: 113 with distal bifurcation and 36 with ostial/body lesion. Triple-vessel disease was significantly higher in the distal than in the ostial/body group (52.2% vs 33.2%, P=.05). At 6-years of follow-up, the cumulative major adverse cardiovascular event rate was 41.6% (45.1% distal vs 30.6% ostial/body, P=0.1), including 18.8% any death (22.1% distal vs 8.3% ostial/body, P=.08), 3.4% myocardial infarction (3.5% distal vs 2.8% ostial/body, P=1), and 15.4% target lesion revascularization (18.6% distal vs 5.6% ostial/body, P=.06). The composite of cardiac death and myocardial infarction was 10.7% (13.3% distal vs 2.8% ostial/body, P=.1) while the definite/probable stent thrombosis rate was 1.4% (all in the distal group).

Conclusions

At 6-year clinical follow-up, percutaneous coronary intervention with drug-eluting stent implantation for unprotected left main disease was associated with acceptable rates of cardiac death, myocardial infarction and stent thrombosis. Favorable long-term outcomes in ostial/body lesions compared to distal bifurcation lesions were confirmed at long-term clinical follow-up.Full English text available from:www.revespcardiol.org/en     

Análisis transversal de la resincronización cardiaca en España. Indicaciones,técnicas de implante,optimización y seguimiento

Introduction and objectives

A cross-sectional study of cardiac resynchronization therapy use in Spain was performed to analyze problems with indications, implantation, and patient follow-up.

Methods

Spanish cardiac resynchronization therapy implanter centers were identified, then the department members were surveyed and the data were recorded by each implantation team.

Results

Eighty-eight implanter centers were identified; of these, 85 (96.6%) answered the survey. A total of 2147 device implantations were reported, comprising 85.6% of the overall number of 2518 implantations estimated by the European Confederation of Medical Suppliers Associations for the same period. The reported implantation rate was 46 per million inhabitants versus an estimated implantation rate of 51 per million (European average, 131). Cardiac resynchronization therapy devices accounted for 84% of implantations, and upgrades to previously implanted devices, 16%. The majority of cardiac resynchronization therapy devices were implanted in men (70.7%). The mean age was 68 (12) years, and the mean left ventricular ejection fraction was 26.4% (5%). Most patients (67%) were in New York Heart Association functional class III. The group of patients for whom cardiac resynchronization therapy was indicated according to the latest update of the guidelines was significant: 17.3% among New York Heart Association class II patients and more than 21.6% among patients with atrial fibrillation. In all, electrophysiologists accounted for 73.8% of implanters, followed by surgeons, accounting for 21.4%.

Conclusions

The latest update of the guidelines is being progressively implemented in Spain, according to data obtained in patients in New York Heart Association class II or with atrial fibrillation. Nevertheless, the number of cardiac resynchronization therapy device implants is still well below the European average.Full English text available from:www.revespcardiol.org     

Validez y aplicabilidad de un nuevo método de registro para la hipertensión arterial

Introduction and objectives

Blood pressure measurement methods and conditions are determinants of hypertension diagnosis. A recent British guideline recommends systematic 24-h ambulatory blood pressure monitoring. However, these devices are not available at all health centers and they can only be used by 1 patient per day. The aim of this study was to test a new blood pressure recording method to see if it gave the same diagnostic results as 24-h blood pressure monitoring.

Methods

One-hour blood pressure monitoring under routine clinical practice conditions was compared with standard method of day time recording by analyzing the coefficient of correlation and Bland-Altman plots. The Kappa index was used to calculate degree of agreement. Method sensitivity and specificity were also analyzed.

Results

Of the 102 participants, 89 (87.3%) obtained the same diagnosis regardless of method, with high between-method agreement (κ= 0.81; 95% confidence interval, 0.71-0.91). We observed robust correlations between diastolic (r = 0.85) and systolic blood pressure (r = 0.76) readings. Sensitivity and specificity for the new method for diagnosing white coat hypertension were 85.2% (95% confidence interval 67.5%-94.1%) and 92% (95% confidence interval, 83.6%-96.3%), respectively.

Conclusions

One-hour blood pressure monitoring is a valid and reliable method for diagnosing hypertension and for classifying hypertension subpopulations, especially in white coat hypertension and refractory hypertension. This also leads to a more productive use of monitoring instruments.Full English text available from:www.revespcardiol.org/en     

Análisis coste-efectividad de dabigatrán para la prevención de ictus y embolia sistémica en fibrilación auricular no valvular en España

Introduction and objectives

Assessment of the cost-effectiveness of dabigatran for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation in Spain, from the perspective of the National Health System.

Methods

Adaptation of a Markov chain model that simulates the natural history of the disease over the lifetime of a cohort of 10 000 patients with non-valvular atrial fibrillation. Model comparators were warfarin in a first scenario, and a real world prescribing pattern in a second scenario, in which 60% of the patients were treated with vitamin K antagonists, 30% with acetylsalicylic acid, and 10% received no treatment. Deterministic and probabilistic sensitivity analyses were performed.

Results

Dabigatran reduced the occurrence of clinical events in both scenarios, providing gains in quantity and quality of life. The incremental cost-effectiveness ratio for dabigatran compared to warfarin was 17 581 euros/quality-adjusted life year gained and 14 118 euros/quality-adjusted life year gained when compared to the real world prescribing pattern. Efficiency in subgroups was demonstrated. When the social costs were incorporated into the analysis, dabigatran was found to be a dominant strategy (ie, more effective and less costly). The model proved to be robust.

Conclusions

From the perspective of the Spanish National Health System, dabigatran is an efficient strategy for the prevention of stroke in patients with non-valvular atrial fibrillation compared to warfarin and to the real-world prescribing pattern; incremental cost-effectiveness ratios were below the 30 000 euros/quality-adjusted life year threshold in both scenarios. Dabigatran would also be a dominant strategy from the societal perspective, providing society with a more effective therapy at a lower cost compared to the other 2 alternatives.Full English text available from:www.revespcardiol.org     

Factores asociados y análisis descriptivo de la endocarditis infecciosa adquirida en el entorno hospitalario de un centro terciario de referencia

Introduction and objectives

The primary aim of this study was to evaluate associated factors, clinical features and prognosis of healthcare-related infective endocarditis cases compared with community-acquired and intravenous drug user-related episodes. Changes in the distribution of healthcare-related infective endocarditis were also analysed over time in our setting.

Methods

A prospective, observational, comparative study was performed. We included all the cases of infective endocarditis from January 2003 to June 2010, which were then classified into 2 groups: group 1: community-acquired and intravenous drug user origin, and group 2: nosocomial and non-nosocomial healthcare-related cases. The episodes were classified into 2 periods: period I: January/2003-June/2006 and period II: July/2006-June 2010. Univariate and multivariate analyses were performed.

Results

A total of 212 cases were included (group 1: 138, group 2: 74). The variables of age (risk ratio 1.026; 95% CI, 1.003 to 1.049), Charlson index (risk radio 1.242; 95% CI, 1.067 to 1.445), and previous heart surgery (risk ratio 2.522; 95% CI, 1.353 to 4.701) were independently associated with healthcare-related infective endocarditis on multivariate analysis. A non-significant increase was observed in healthcare-related cases of infective endocarditis in period II (40/104; 38.4% vs. 34/108; 31.4%).

Conclusions

The recent increase in healthcare-related infective endocarditis seems to be associated with the use of invasive procedures in elderly patients with prosthetic cardiac valve, and those with a greater number of underlying diseases, especially patients with chronic renal failure on haemodialysis.     

Análisis de la variación intraespecífica de Conidiobolus coronatus usando RAPD y secuencias ITS

Introduction

The fungus Conidiobolus coronatus (C. coronatus) has an extensive distribution of habitats and hosts. It is found saprophytically, and attacks insects and mammals, including humans. Although there are few reports on humans, and they are restricted to tropical areas. The aim of this work was to determine whether genetic variation exists between C. coronatus isolates coming from human lesions and other sources.

Methods

A total of 11 C. coronatus isolates obtained from soil, insects and humans were analyzed with the random amplification of polymorphic ADN (RAPD) and internal transcribed spacer (ITS) techniques; the maximum parsimony, neighbour-joining and minimum evolution methods were used for the ITS analysis.

Results

The analysis of the C. coronatus polymorphisms showed high intra-species variation levels between the evaluated isolates. The isolates coming from human lesions showed the greatest genetic divergence compared with the remaining isolates. The greatest genetic distance between isolate groups was found between those coming from humans and those taken from the insect Lycoriella ingenua.

Conclusions

This is the very first work evaluating and demonstrating that within species variation exists at molecular level in C. coronatus, and is related to the source where the isolates were taken from.     

El cigarrillo electrónico. Declaración oficial de la Sociedad Española de Neumología y Cirugía Torácica (SEPAR) sobre la eficacia,seguridad y regulación de los cigarrillos electrónicos

The electronic cigarette (EC) is a device formed by three basic elements: battery, atomizer and cartridge. When assembled, it looks like a cigarette. The cartridge contains different substances: propylene glycol, glycerine and, sometimes, nicotine. When the user “vapes”, the battery is activated, the atomizer is heated and the liquid is drawn in and vaporized. The smoker inhales the mist produced. Various substances have been detected in this mist: formaldehyde, acetaldehyde and acrolein and some heavy metals. Although these are found in lower concentrations than in cigarettes, they may still be harmful for the human body. Several surveys show that 3-10% of smokers regularly use e-cigarettes. A randomized study has shown that the efficacy of e-cigarettes for helping smokers to quit is similar to nicotine patches. Nevertheless, the study has relevant methodological limitations and reliable conclusions cannot be deduced. This report sets down the Position Statement of the Spanish Society of Pulmonology and Thoracic Surgery (SEPAR) on the efficacy and safety of e-cigarettes. This statement declares that e-cigarettes should be regulated as medicinal products.     

Asociación entre adiposidad corporal y presión arterial entre los 6 y los 16 años. Análisis en una población escolar madrileña

Introduction and objectives

The increase in the incidence of hypertension in children can be attributed to the rising prevalence of obesity. The objective is to analyze the impact of overweight and the degree or distribution of adiposity on blood pressure levels in a population of Spanish schoolchildren.

Methods

A cross-sectional study was carried out in 1511 schoolchildren between 6 years and 16 years of age. We measured weight, height, waist circumference, subcutaneous skinfolds, and blood pressure. Nutritional categories were established on the basis of body mass index, waist-to-height ratio, and percent body fat. According to the National High Blood Pressure Education Program Working Group, subjects whose blood pressure was above the 90th percentile of the standard normal distribution were considered to have high blood pressure.

Results

In all, 3.17% of the boys and 3.05% of the girls had high blood pressure. According to odds ratio analysis, the risk of high blood pressure increased in individuals with a body mass index indicative of obesity (7.87-fold in boys, 12.32-fold in girls), with a percent body fat>97th percentile (6.98-fold in boys, 18.51-fold in girls), or with a waist-to-height ratio≥0.5 (10.56-fold in boys, 7.82-fold in girls).

Conclusions

Overweight and obesity increase the risk of high blood pressure in children between 6 years and 16 years of age, although the risk level varies depending on the amount and distribution of adipose tissue. Anthropometric indicators of relative adiposity and fat distribution are especially useful in the identification of children and adolescents with high blood pressure.Full English text available from:www.revespcardiol.org/en     

Manejo de la hipertensión resistente en una unidad multidisciplinaria de denervación renal: protocolo y resultados

Introduction and objectives

Resistant hypertension is a clinical problem because of its difficult management and increased morbidity and mortality. Catheter-based renal denervation has been demonstrated to improve control in these patients. The results of establishing a multidisciplinary unit for the implementation of renal denervation in the management of resistant hypertension are described.

Methods

A team of nephrologists and cardiologists created a protocol for patient selection, intervention, and follow-up. One hundred and ninety-seven patients with poorly controlled essential hypertension, despite taking 3 or more drugs, were included. The ablation technique previously described was supported by a navigator based on rotational angiography. Blood pressure at baseline and after follow-up was compared using the Wilcoxon test for paired samples.

Results

One hundred and eight patients (55%) with pseudo-resistant hypertension were excluded. The other 89 were given antialdosteronic drugs, to which 60 patients (30%) responded. The remaining 29 patients (15%) were candidates for denervation. Eleven patients, with blood pressure 164/99 mmHg and taking 4.4 antihypertensive drugs, were ablated. After 72 days of follow-up, systolic and diastolic blood pressure fell by 25 mmHg (P=.02) and 10 mmHg (P=.06), respectively. In 10 patients (91%) at least 1 drug was discontinued.

Conclusions

Renal denervation performed by a multidisciplinary team led to an improvement in blood pressure similar to previous studies, with a greater reduction of antihypertensive drugs.Full English text available from:www.revespcardiol.org/en.     

Asociación entre presión arterial y mortalidad en una cohorte de individuos de edad igual o superior a 65 años de España: un modelo dinámico

Introduction and objectives

Few studies have used time-dependent correction to analyze the relationship between blood pressure and all-cause mortality, and to our knowledge none has been performed in older people from the Mediterranean area. This study aimed to estimate the relationship between baseline blood pressure and blood pressure as a time-dependent covariate with the risk of all-cause mortality in a population cohort of persons aged 65 or older in Spain.

Methods

Data were taken from the population-based study «Aging in Leganés» with 17 years of follow-up, launched in 1993 in a random sample (n=1560) of persons aged ≥65 years. Mortality was assessed in 2010. Cox proportional hazards models were fitted to examine the effects on mortality of blood pressure at baseline and of blood pressure as a time-dependent covariate.

Results

The lowest mortality was observed at baseline systolic blood pressure of 136 mmHg and time-dependent covariate value of 147 mmHg. The highest risk of mortality for time-dependent covariates occurred with systolic blood pressure<115 mmHg and >93 mmHg and diastolic blood pressure<80 mmHg. Diastolic blood pressure over 85 mmHg did not increase the risk of death.

Conclusions

Based on the dynamic association between blood pressure and mortality, a U-shaped relationship was found for systolic blood pressure and a negative relationship for diastolic blood pressure and all-cause mortality. The lowest mortality corresponded to a systolic blood pressure level slightly over the diagnostic hypertension value and suggests that a value of 140 mmHg is not adequate as a diagnostic and therapeutic threshold in an elderly population.Full English text available from:www.revespcardiol.org/en.     

Hipertensión intraabdominal: consecuencias sobre la circulación esplácnica. Estudio preliminar en un modelo de ascitis

Introduction

Intra-abdominal hypertension is defined as a rise in intra-abdominal pressure leading to progressive dysfunction of the abdominal organs.

Objective

To evaluate the effects of intra-abdominal hypertension on the splanchnic circulation in a porcine animal model with a view to determining the diagnostic method of choice.

Material and methods

A total of 10 swine were divided into 2 groups: a control group and a group with an ascites pressure of 20 mmHg. Transvesical and transperitoneal intra-abdominal pressures were registered, and the correlation between the measurements obtained was determined. Concentrations of lactic acid, alanine aminotransferase, glucose and gastric mucosal pH were also obtained. We registered the mean arterial and abdominal perfusion pressures, and the correlation of the latter with gastric mucosal pH and lactic acid concentrations. The parameters were registered for a total of 3 hours.

Results

We observed a high correlation between transvesical and transperitoneal measurements of intra-abdominal pressure (R² = 0.98). In the 20 mmHg pressure group, lactic acid concentrations increased significantly at 180 min (p < 0.011). Gastric mucosal pH differed significantly between the 2 groups from the beginning of the study (p = 0.004) and significantly decreased from 120 min onward. Mean arterial and abdominal perfusion pressures gradually decreased during the trial, with early significant changes in the abdominal perfusion pressure (p = 0.001), and a good correlation with the remaining study parameters. There were no significant changes in hepatic indicators.

Conclusions

We believe the transvesical approach to be the technique of choice to determine intra-abdominal pressure. Abdominal perfusion pressure is a sensitive marker of intra-abdominal hypertension, and gastric mucosal pH is the first parameter to be affected.     

Eficacia y seguridad a más de 10 años de la ablación septal percutánea en la miocardiopatía hipertrófica obstructiva

Introduction and objectives

Percutaneous transluminal septal ablation is an alternative treatment in patients with hypertrophic obstructive cardiomyopathy. However, due to the relatively new introduction of this technique, there is no information on its very long term results (>10 years).

Methods

The present study included consecutive patients treated in 5 centers between 1998 and 2003. We analyzed clinical, hemodynamic, and echocardiographic data at baseline and follow-up.

Results

A total of 45 patients were included; there were 31 (69%) women, the mean age was 62.4 (14) years, and 39 patients (86.6%) showed functional class III or IV. Septal thickness was 21.8 (3.5) mm, the peak resting gradient on echocardiography was 77 (39) mmHg, and mitral regurgitation was at least moderate in 22 patients (48.8%). During hospitalization, permanent pacemaker implantation was required in 3 patients and ventricular perforation (by pacing lead) occurred in 1 patient, requiring surgery. After a follow-up of 12.3 years (11.0-13.5 years), 2 patients (4.4%) died from cardiac causes (heart failure and posttransplantation), 3 patients required an implantable cardioverter-defibrillator (1 for primary prevention and 2 due to sustained ventricular tachycardia after cardiac surgery), and 2 underwent cardiac surgery (due to endocarditis and mitral regurgitation). In the last clinical review, functional class was I-II in 39 patients (86.6%) (P<.0001), the peak resting gradient was 16 (23) mmHg (P<.0001), and mitral regurgitation was absent or mild in 34 patients (75.5%) (P<.03).

Conclusions

The results of this study suggest that septal ablation is safe and effective in the very long term. The procedure was not associated with a significant incidence of sudden death or symptomatic ventricular arrhythmias.Full English text available from:www.revespcardiol.org/en     

Análisis combinado de dos ensayos aleatorizados de comparación de stents con recubrimiento de titanio-óxido nítrico con stents liberadores de fármacos en el IAMCEST

Introduction and objectives

We performed a pooled analysis based on patient-level data from the TITAX-AMI and BASE-ACS trials to evaluate the outcome of titanium-nitride-oxide-coated bioactive stents vs drug-eluting stents in patients with ST-segment elevation myocardial infarction at 2-year follow-up.

Methods

The TITAX-AMI trial compared bioactive stents with paclitaxel-eluting stents in 425 patients with acute myocardial infarction. The BASE-ACS trial compared bioactive stents with everolimus-eluting stents in 827 patients with acute coronary syndrome. The primary endpoint for the pooled analysis was major adverse cardiac events: a composite of cardiac death, recurrent myocardial infarction, or ischemia-driven target lesion revascularization at 2-year follow-up.

Results

The pooled analysis included 501 patients; 245 received bioactive stents, and 256 received drug-eluting stents. The pooled bioactive stent group was associated with a risk ratio of 0.85 for major adverse cardiac events (95% confidence interval, 0.53-1.35; P = .49) compared to the pooled drug-eluting stent group. Similarly, the pooled bioactive stent group was associated with a risk ratio of 0.71 for cardiac death (95% confidence interval, 0.26-1.95; P = .51), 0.44 for recurrent myocardial infarction (95% confidence interval, 0.20-0.97; P = .04), and 1.39 for ischemia-driven target lesion revascularization (95% confidence interval, 0.74-2.59; P = .30), compared to the pooled drug-eluting stent group. These results were confirmed by propensity-score adjusted analysis of the combined datasets.

Conclusions

In patients with ST-segment elevation myocardial infarction, bioactive stents were associated with lower rates of recurrent myocardial infarction compared to drug-eluting stents at 2-year follow-up; yet, the rates of cardiac death and ischemia-driven target lesion revascularization were similar.Full English text available from: www.revespcardiol.org/en