Robotic Assisted Transanal Polypectomies: Is There Any Indication? / Polipectomía transanal asistida por robot: ¿tiene alguna indicación?

OBJECTIVES: Robotic assisted transanal polipectomy may have advantages compared with the conventional transanal minimally invasive surgery technique. We evaluate the safety, feasibility and advantages of this technique. METHODS: Between February 2014 and October 2015, 9patients underwent robotic transanal polypectomy. We performed a retrospective study in which we analyse prospectively collected data regarding patient and tumor characteristics, perioperative outcomes, pathological report, morbidity and mortality. RESULTS: A total of 5 male and 4 female patients underwent robotic TAMIS. Lesions were 6,22cm from the anal verge. Mean size was 15,8cm2. All procedures were performed in the lithotomy position. Closure of the defect was performed in all cases. Mean blood loss was 39,8ml. Mean operative time was 71,9min. No severe postoperative complications or readmissions occured. Median hospital stay was 2,5 days. CONCLUSIONS: Robotic TAMIS is useful to treat complex rectal lesions. Our transanal platform allowed a wider range of movements of the robotic arms and to perform all procedures in the lithotomy position.

New technique of transanal proctectomy with completely robotic total mesorrectal excision for rectal cancer.

Anterior resection with total mesorectal excision is the standard method of rectal cancer resection. However, this procedure remains technically difficult in mid and low rectal cancer. A robotic transanal proctectomy with total mesorectal excision and laparoscopic assistance is reported in a 57 year old male with BMI 32 kg/m2 and rectal adenocarcinoma T2N1M0 at 5 cm from the dentate line. Operating time was 420 min. Postoperative hospital stay was 6 days and no complications were observed. Pathological report showed a 33 cm specimen with ypT2N0 adenocarcinoma at 2 cm from the distal margin, complete TME and non affected circumferential resection margin. Robotic technology might reduce some technical difficulties associated with TEM/TEO or SILS platforms in transanal total mesorectal excision. Further clinical trials will be necessary to assess this technique.

[Transanal endoscopic operations for rectal tumours]. / Cirugía endoscópica transanal en tumores rectales.

BACKGROUND: Transanal endoscopic operation (TEO) may be the technique of choice for the treatment of rectal lesions, both benign and selected malignant lesions, with similar survival rates to conventional surgery but with lower morbidity. METHODS: In this article we present a series of 70 patients operated on with this procedure (TEO) in our center. The indications were benign rectal lesions and malignant lesions at early stages (T1) 86%. The surgical procedure was performed with the the transanal endoscopic operation platform (TEO; Karl Storz, Tüttlingen, Germany) and ultrasonic scalpel (Harmonic scalpel, Ethicon Endo-surgery,…). RESULTS: The indication in 43 patients was a benign lesion (adenoma), in the other 27 the diagnosis was adenocarcinoma. After the resection, 61% of the series had a malignant lesion in the pathology report: 13 patients of the 43 with a benign lesion initially had a malignant lesion in the pathology report. Postoperative morbidity was 36%, Clavien III (5,7%). 3 patients (4%) needed emergency surgery. All of the benign lesions were completely excised, but 7 malignant lesions had resection margin involvement The median follow-up time was 26,4 months (range, 1-71 months), the overall recurrence for benign tumors was 9%, 8% for malignant pT1 and 12,5% for malignant pT2. Early salvage surgery was performed on 8 patients. CONCLUSIONS: TEO allows us to excise benign rectal lesions that could not be excised with a conventional approach (endoscopic or transanal resection) with a low morbidity rate. TEO can be used for malignant rectal tumors in early stages (pT1) with pathological confirmation.

[Effects of surgical simulation on the implementation of laparoscopic colorectal procedures]. / Efecto de la simulación quirúrgica en la implementación clínica de procedimientos colorrectales laparoscópicos.

INTRODUCTION: Advanced laparoscopic surgery requires supplementary training outside the operating room. Clinical simulation with animal models or cadavers facilitates this learning. OBJECTIVE: We measured the impact on clinical practice of a laparoscopic colorectal resection training program based on surgical simulation. MATERIAL AND METHODS: Between March 2007 and March 2012, 163 surgeons participated in 30 courses that lasted 4 days, of 35 hours (18 h in the operating room, 12h in animal models, and 4h in seminars). In May 2012, participants were asked via an on-line survey about the degree of implementation of the techniques in their day-to-day work. RESULTS: Seventy surgeons (47%) from 60 different hospitals answered the survey. Average time elapsed after the course was 11.5 months (2-60 months). A total of 75% initiated or increased the number of surgeries performed after the training. The increase in practice was>10 cases/month in 19%, and<5 cases/month in 56% of surgeons. 38% of participants initiated this surgical approach. CONCLUSIONS: Seventy five percent of the surveyed surgeons increased the clinical implementation of a complicated surgical technique, such as laparoscopic colorectal surgery, after attending a training course based on clinical simulation.

Coexistent HCN4 and GATA5 Rare Variants and Atrial Fibrillation in a Large Spanish Family.

BACKGROUND: Familial association of atrial fibrillation (AF) can involve single gene variants related to known arrhythmogenic mechanisms; however, genome-wide association studies often disclose complex genetic variants in familial and nonfamilial AF, making it difficult to relate to known pathogenetic mechanisms. METHODS: The finding of 4 siblings with AF led to studying 47 members of a family. Long-term Holter monitoring (average 298 hours) ruled out silent AF. Whole-exome sequencing was performed, and variants shared by the index cases were filtered and prioritised according to current recommendations. HCN4 currents (IHCN4) were recorded in Chinese hamster ovary cells expressing human p.P1163H or native HCN4 channels with the use of the patch-clamp technique, and topologically associating domain analyses of GATA5 variant were performed. RESULTS: The clinical study diagnosed 2 more AF cases. Five family members carried the heterozygous p.P1163H HCN4 variant, 14 carried the intronic 20,61040536,G,A GATA5 rare variant, and 9 carried both variants (HCN4+GATA5). Five of the 6 AF cases (onset age ranging from 33 to 70 years) carried both variants and 1 carried the GATA5 variant alone. Multivariate analysis showed that the presence of HCN4+GATA5 variants significantly increased AF risk (odds ratio 32.7, 95% confidence interval 1.8-591.4) independently from age, hypertension, and overweight. Functional testing showed that IHCN4 generated by heterozygous p.P1163H were normal. Topologically associating domain analysis suggested that GATA5 could affect the expression of many genes, including those encoding microRNA-1. CONCLUSION: The coincidence of 2 rare gene variants was independently associated with AF, but functional studies do not allow the postulation of the arrhythmogenic mechanisms involved.

Absence of High Lipoprotein(a) Levels Is an Independent Predictor of Acute Myocardial Infarction without Coronary Lesions.

The pathophysiological mechanisms underlying Myocardial Infarction with Non-Obstructive Coronary Artery Disease (MINOCA) are still under debate. Lipoprotein (a) [Lp(a)] has proinflammatory and prothrombotic actions and has been involved in the pathogenesis of atherosclerosis. However, no previous studies have linked Lp(a) levels with the probability of developing MINOCA. Moreover, the relationship between MINOCA and the plasma levels of other proatherogenic and proinflammatory molecules such as Interleukin-18 (IL18) and proprotein convertase subtilisin/kexin type 9 (PCSK9) has not been studied. We conducted a prospective, multicenter study involving 1042 patients with acute myocardial infarction (AMI). Seventy-six patients had no significant coronary lesions. All patients underwent plasma analysis on admission. MINOCA patients were younger (57 (47-68) vs. 61 (52-72) years; p = 0.010), more frequently female (44.7% vs. 21.0%; p < 0.001), and had lower rates of diabetes and of Lp(a) > 60 mg/dL (9.2% vs. 19.8%; p = 0.037) than those with coronary lesions; moreover, High Density Lipoprotein cholesterol (HDL-c) levels were higher in MINOCA patients. The absence of Lp(a) > 60 mg/dL and of diabetes were independent predictors of MINOCA, as well as female sex, high HDL-c levels, and younger age. IL-18 and PCSK9 levels were not predictors of MINOCA. During a follow-up of 5.23 (2.89, 7.37) years, the independent predictors of the primary outcome (acute ischemic events or death) in the whole sample were Lp(a) > 60 mg/dL, older age, low estimated Glomerular Filtration rate (eGFR), hypertension, previous heart failure (HF), coronary artery bypass graft, use of insulin, and no therapy with acetylsalicylic acid. In conclusion, in AMI patients, the absence of high Lp(a) levels, as well high HDL-c levels, were independent predictors of the inexistence of coronary artery disease. High Lp (a) levels were also an independent predictor of ischemic events or death.

Prevalence and prognosis of anxiety, insomnia, and type D personality in patients with myocardial infarction: A Spanish cohort.

BACKGROUND: It has been suggested that patients with myocardial infarction and non-obstructive coronary arteries (MINOCA) have more psycho-emotional disorders than patients with obstructive coronary artery disease (MICAD). The aim of this study is to compare the prevalence of anxiety, insomnia, and type D personality between MINOCA and MICAD and their impact on prognosis. METHODS: Patients with myocardial infarction undergoing coronary angiography were prospectively enrolled. Psychological questionnaires were completed by each patient during admission. RESULTS: Among a total of 533 patients, 56 had MINOCA and 477 had MICAD. There were no differences in the prevalence of anxiety and insomnia between both groups: trait anxiety median value (M) MINOCA = 18 (11-34) vs. MICAD M = 19 (12-27), p = 0.8; state anxiety MINOCA M = 19 (11-29) vs. MICAD M = 19 (12.2-26), p = 0.6; and insomnia MINOCA M = 7 (3-11) vs. MICAD M = 7 (3-12), p = 0.95. More MINOCA patients had type D personality (45.0% vs. 28.5%, p = 0.03). At 3-year follow-up, there were no differences in mortality between MINOCA and MICAD (hazard ratio [HR] 0.78, 95% confidence interval [CI] 0.28-2.17) in major adverse cerebral or cardiovascular events (MACCE) (HR 0.71, 95% CI 0.38-1.31). Scores of trait anxiety and negative affectivity were significantly associated with MACCE (HR 1.65, 95% CI [1.05-2.57]; HR 1.75, 95% CI [1.11-2.77], respectively). High insomnia levels were associated with greater mortality (HR 2.72, 95% CI [1.12-6.61]). CONCLUSIONS: Anxiety and insomnia levels were similar between patients with MINOCA and those with MICAD, whilst the prevalence of type D personality was higher in the MINOCA than in the MICAD group. Higher scores in trait anxiety, insomnia, and negative affectivity were related to a worse prognosis at 3-year follow-up.

Incidence of long-term cardiotoxicity and evolution of the systolic function in patients with breast cancer treated with anthracyclines.

BACKGROUND: Anthracycline cardiotoxicity (AC) may manifest years after treatment (long-term cardiotoxicity). There is little data on the incidence and natural history of AC in the current context, with protocols including lower anthracycline doses. The present study prospectively evaluated the incidence, time of occurrence and clinical correlates of long-term cardiotoxicity and the evolution of systolic function in patients with breast cancer treated with anthracyclines. METHODS: This study prospectively included 85 consecutive patients undergoing chemotherapy (CHT) with anthracyclines without trastuzumab. All patients underwent evaluation at baseline, at the end of CHT, 3 months after the end of CHT and 1 and 4 years subsequent to the beginning of CHT. Clinical data and echocardiographic parameters were evaluated in all examinations. RESULTS: The mean dose of doxorubicin used was 243.53 mg/m2. Median follow-up of the current cohort was 4.5 years. At 1 year the incidence of AC was 1% and at the end of the follow-up 16.5% (14 of 85 patients). Therefore, the incidence of late cardiotoxicity (after the first year) was 15%. Of these 14 patients with AC, 12 had asymptomatic systolic dysfunction, 1 had heart failure and 1 suffered sudden death. Fifteen percent developed systolic dysfunction during follow-up. An early decline in strain was observed in patients who developed long-term AC. CONCLUSIONS: The incidence of long-term cardiotoxicity in patients treated with low-cumulative dose of anthracyclines is high, 16.5% at 4.5 years. This was observed in almost all cases after the first year of follow-up. Therefore, long-term monitoring may be advisable.

Clinical characteristics and prognosis of myocardial infarction with non-obstructive coronary arteries: A prospective single-center study.

BACKGROUND: A definition of myocardial infarction with non-obstructive coronary arteries (MINOCA) was published by European Society of Cardiology in 2016. The aim of this study is to analyze the clinical profile and prognosis of these patients in a prospective single-center study and compare it with the literature data. METHODS: During a 3-year period, information from every consecutive MINOCA patient was gathered (n = 109). It was then compared with 412 contemporaneous patients with myocardial infarction and obstructive coronary arteries (MIOCA). Univariate and multivariate analyses were performed. Prognosis analysis was adjusted by age and cardiovascular risk factors (CVRF). RESULTS: MINOCA represented 16.9% of the total of patients admitted for myocardial infarction (MI). Compared with MIOCA, they had more psychosocial disorders (22.9% vs. 10.7%; p < 0.01) and more pro-inflammatory conditions (34.9% vs. 14.0%; p < 0.01). Atrial fibrillation was twice as frequent in MINOCA (14.7% vs. 7.3%; p = 0.016). Predictors of MINOCA were as follows: female gender, absence of diabetes, absence of tobacco use, tachycardia, troponin above 10 times the 99th percentile, and proinflammatory conditions. Median follow-up was 17.3 ± 9.3 months. Major adverse cardiovascular events (MACE; a composite of a recurrence of acute MI, transient ischemic attack/stroke, or death from cardiovascular cause and death from any cause) occurred in 10.8% of the MINOCA group as compared with 10.7% in the MIOCA group (hazard ratio [HR] 1.19, 95% confidence interval [CI] 0.58-2.45; p = 0.645). Cardiovascular re-admission rates were higher in the MINOCA group: 19.8% vs. 13.9% (HR 1.85; CI 1.06-3.21; p = 0.030). CONCLUSIONS: The frequency of MINOCA is high, with fewer CVRF, and it is linked to atrial fibrillation, psychosocial disorders, and pro-inflammatory conditions. Mid-term prognosis is worse than previously thought, with a similar proportion of MACE as compared to MIOCA, and even a higher rate of cardiovascular re-admissions.

Differences Between Takotsubo and the Working Diagnosis of Myocardial Infarction With Nonobstructive Coronary Arteries.

Aim: Whether Takotsubo syndrome (TTS) should be classified within myocardial infarction with non-obstructive coronary arteries (MINOCAs) is still controversial. The aim of this work was to evaluate the main differences between TTS and non-TTS MINOCAs. Methods and Results: A cohort study based on two prospective registries: TTS from the RETAKO registry (N:1,015) and patients with non-TTS MINOCAs from contemporary records of acute myocardial infarction from five 5 national centers (N:1,080). Definitions and management recommended by the ESC were used. Survival analysis was based on the Cox regression analysis; propensity score matching (PS) was created to adjust prognostic variables. Takotsubo syndrome were more often women (85.9 vs. 51.9%; p < 0.001) and older (69.4 ± 12.5 vs. 64.5 ± 14.1 years; p < 0.001). Atrial fibrillation (AF) was more frequent in non-TTS MINOCAs (10.4 vs. 14.4%; p = 0.007). Psychiatric disorders were more prevalent in TTS (15.5 vs. 10.2%, p < 0.001). In-hospital mortality and complications were higher in TTS: 3.4 vs. 1.8%, (p = 0.015), and 25.8 vs. 11.5%, (p < 0.001). Global mortality before PS matching was 16.1% in non-TTS MINOCAs and 8.1% in TTS. Median follow-up was 32.4 months; after PS matching, TTS had fewer major adverse cardiovascular events (MACEs): hazard ratio (HR) 0.59; 95% CI 0.42-0.83. There were no differences in global mortality (HR 0.87; CI: 0.64-1.19), but TTS had lower cardiovascular mortality (HR 0.58; CI: 0.35-0.98). Conclusion: Compared to the rest of MINOCAs, TTS presents a different patient profile and a more aggressive acute phase. However, its long-term cardiovascular prognosis is better. These results support that TTS should be considered a separate entity with unique characteristics and prognosis.

Relationship Between Influenza, Temperature, and Type 1 Myocardial Infarction: An Ecological Time-Series Study.

Background Previous studies investigating the relationship of influenza with acute myocardial infarction (AMI) have not distinguished between AMI types 1 and 2. Influenza and cold temperature can explain the increased incidence of AMI during winter but, because they are closely related in temperate regions, their relative contribution is unknown. Methods and Results The temporal relationship between incidence rates of AMI with demonstrated culprit plaque (type 1 AMI) from the regional primary angioplasty network and influenza, adjusted for ambient temperature, was studied in Madrid region (Spain) during 5 influenza seasons (from June 2013 to June 2018). A time-series analysis with quasi-Poisson regression models and distributed lag-nonlinear models was used. The incidence rate of type 1 AMI according to influenza vaccination status was also explored. A total of 8240 cases of confirmed type 1 AMI were recorded. The overall risk ratio (RR) of type 1 AMI during epidemic periods, adjusted for year, month, and temperature, was 1.23 (95% CI, 1.03-1.47). An increase of weekly influenza rate of 50 cases per 100 000 inhabitants resulted in an RR for type 1 AMI of 1.16 (95% CI, 1.09-1.23) during the same week, disappearing 1 week after. When adjusted for influenza, a decrease of 1ºC in the minimum temperature resulted in an increase of 2.5% type 1 AMI. Influenza vaccination was associated with a decreased risk of type 1 AMI in subjects aged 60 to 64 years (RR, 0.58; 95% CI, 0.47-0.71) and ≥65 years (RR, 0.53; 95% CI, 0.49-0.57). Conclusions Influenza and cold temperature were both independently associated with an increased risk of type 1 AMI, whereas vaccination was associated with a reduced risk among older patients.

Heat waves, ambient temperature, and risk of myocardial infarction: an ecological study in the Community of Madrid.

INTRODUCTION AND OBJECTIVES: Episodes of extreme heat are associated with increased morbidity and mortality in chronically-ill patients but there is a need to clearly establish the relationship between extreme heat and myocardial infarction. The aim of this study was to analyze the relationship between the incidence of ST-segment elevation myocardial infarction (STEMI) and maximum temperature, in particular during heat wave alert periods (HWAP). METHODS: The population studied consisted of confirmed STEMI cases registered in the Infarction Code of the Community of Madrid between June 2013 and June 2017. Incidence rate ratios (IRR) adjusted for trend and seasonality and 95%CI were estimated using time series regression models. RESULTS: A total of 6465 cases of STEMI were included; 212 cases occurred during the 66-day period of HWAP and 1816 cases during the nonalert summer period (IRR, 1.14; 95%CI, 0.96-1.35). The minimum incidence rate was observed at the maximum temperature of 18°C. Warmer temperatures were not associated with a higher incidence (IRR,1.03; 95%CI, 0.76-1.41), whereas colder temperatures were significantly associated with an increased risk (IRR, 1.25; 95%CI, 1.02-1.54). No effect modification was observed by age or sex. CONCLUSIONS: We did not find an increased risk of STEMI during the 66 days of HWAP in the Community of Madrid between June 2013 and June 2017. However, an increased risk was found during colder temperatures. No extra health resources for STEMI management are required during periods of extreme heat, but should be considered during periods of cold weather.

Impact of significant paravalvular leaks after transcatheter aortic valve implantation on anaemia and mortality.

OBJECTIVE: The aim of this work is to assess the relationship between significant paravalvular leak (SPL) after transcatheter aortic valve implantation (TAVI) on anaemia and their impact on prognosis. METHODS: Observational analytic study developed at two university hospitals, including all consecutive patients who underwent TAVI during a 10-year period (2009 to 2018). A logistic regression model was created to determine independent predictors of anaemia at 3 months. Time to event outcomes were analysed with Cox regression. Median follow-up was 21.3±21.9 months. RESULTS: 788 patients were included. 5.3% had SPL. SPL was an independent predictor of anaemia 3 months after TAVI (OR: 8.31, 95% CI: 2.06 to 33.50). SPL and anaemia at 3 months were independently associated with long-term mortality (HR: 1.82, 95% CI: 1.16 to 2.85; HR: 2.07, 95% CI: 1.39 to 3.08). CONCLUSION: SPL is an independent predictor of anaemia at 3 months after TAVI, a condition that doubles long-term mortality. Our findings could explain in part the worse prognosis of SPL after TAVI. Further pathophysiological studies are necessary to explain this association.

The Gender Perspective Within the OFRECE Study: Differences in Health Care Among Patients Consulting for Chest Pain and/or Palpitations.

INTRODUCTION AND OBJECTIVES: To analyze differences between sexes in the clinical management of patients presenting with symptoms of chest pain and/or palpitations within a population-based study. METHODS: The OFRECE study included a random sample of 8400 individuals from the Spanish population aged 40 years and older; 1132 (13.5%) had previously consulted for chest pain and 1267 (15.1%) had consulted for palpitations and were included in the present study. We calculated both the crude and adjusted odds ratios (OR) of undergoing certain tests and the results of consultations by sex. Adjustment was performed by classic cardiovascular risk factors, a personal history of cardiovascular disease, and a diagnosis of stable angina or atrial fibrillation confirmed in the OFRECE study in each case. RESULTS: No differences were observed in history of consultation for chest pain between women and men (13% vs 14.1%; P=.159) but differences were found in palpitations (19% vs 10.4%, respectively; P <.001). Women who had previously consulted for chest pain underwent fewer echocardiograms (32.5% vs 45.3%, respectively; P <.001), were less frequently referred to a cardiologist (49.1% vs 60.1%; P <.001), were less often admitted to hospital (20.1% vs 39.4%; P <.001), and less frequently received a confirmed diagnosis (60.9 vs 71, 9; P <.001). After full adjustment, all differences decreased and become nonsignificant echocardiograms: adjusted OR, 0.81; 95%CI, 0.60-1.09; referral to a cardiologist: adjusted OR, 0.86; 95%CI, 0.63-1.16; hospital admission: adjusted OR, 0.76; 95%CI, 0.54-1.09). For palpitations, crude differences were smaller and all became nonsignificant after adjustment. CONCLUSIONS: This study does not confirm the existence of sex-related bias in the management of chest pain and palpitations. However, such bias cannot be completely ruled out in diagnoses confirmed within the OFRECE study, which might limit its ability to detect sex-related differences in health care.

Abnormal Electrocardiographic Findings in the Population Older Than 40 Years. Prevalence and Clinical Significance. Results of the OFRECE Study.

INTRODUCTION AND OBJECTIVES: Abnormal electrocardiographic findings are highly common. The aim of this study was to analyze the prevalence of abnormal electrocardiographic patterns in the general Spanish population aged 40 years or older. METHODS: This subanalysis of the OFRECE study selected a representative sample of the Spanish population aged 40 years or older. Clinical data and electrocardiograms were available in all participants. The electrocardiograms were read centrally. Each electrocardiogram was independently assessed by 2 trained cardiologists and, if there was disagreement, a third was consulted to reach a consensus-based diagnosis. Prior to reading the electrocardiograms, diagnostic criteria were strictly defined for each of the abnormalities analyzed. We analyzed the prevalence and clinical factors associated with cavity enlargement, conduction disorders, repolarization abnormalities, pathological Q waves, atrial and ventricular premature beats, and pre-excitation. RESULTS: A total of 8343 individuals were evaluated, (mean age, 59.2 years; 52.4% women). Only 4074 (51.2%) participants had a completely normal electrocardiogram. The most frequent abnormalities were nonspecific repolarization abnormalities (16%) associated with coronary heart disease and atrial fibrillation; right bundle-branch block (8.1%) associated with chronic pulmonary obstructive disease; left anterior hemiblock (6.5%) related to hypertension and congestive heart failure; and long PR interval (3.7%), which was associated with coronary heart disease. CONCLUSIONS: Electrocardiographic abnormalities are very common in the general population aged 40 years or older. Only about half of the population had a completely normal electrocardiogram.

Cardiologists and the Cardiology of the Future. Vision and proposals of the Spanish Society of Cardiology for the Cardiology of the 21st Century.

The Cardiology of the Future is a project of the Spanish Society of Cardiology (SEC) whose objectives are as follows: to define the action policies of the SEC; to analyze the trends and changes in the environment that will influence the practice of cardiology in Spain; to define the profile of the cardiologists needed in the future; to propose policies to achieve the objectives resulting from the identified needs; and to identify the role of the SEC in the development and implementation of these policies. This article describes the methodology and the most relevant findings of the final report of this project and the strategic lines to be developed by the SEC in the immediate future, resulting from the analysis performed.

Prevalence of Electrocardiographic Patterns Associated With Sudden Cardiac Death in the Spanish Population Aged 40 Years or Older. Results of the OFRECE Study.

INTRODUCTION AND OBJECTIVES: Some electrocardiographic patterns are associated with an increased risk of sudden cardiac death due to ventricular arrhythmias. There is no information on the prevalence of these patterns in the general population in Spain. The objective of this study was to analyze the prevalence of these patterns and associated clinical and epidemiological factors. METHODS: This subanalysis of the OFRECE study selected a representative sample of the Spanish population aged ≥ 40 years. We studied the presence or absence of electrocardiographic patterns of Brugada syndrome and QT interval abnormalities. Clinical data and electrocardiograms were available in all participants. Electrocardiograms were evaluated by 2 cardiologists and a third cardiologist was consulted if there was disagreement in the diagnosis. We calculated the weighted prevalence and clinical factors associated with the presence of Brugada-type patterns or QT segment abnormalities. RESULTS: Overall, 8343 individuals were evaluated (59.2 years, 52.4% female). There were 12 Brugada cases (type 1, 2 cases; type 2, 10 cases; weighted prevalence, 0.13%). For corrected QT (QTc) analysis, we excluded participants with left bundle branch block or without sinus rhythm. Weighted prevalences were as follows: short QTc (< 340ms) 0.18%, borderline QTc (441-469ms) 8.33%, long QTc (≥ 470ms criterion) 1.01% and long QTc (≥ 480 criterion) 0.42%. CONCLUSIONS: A total of 0.6% to 1.1% of the Spanish population aged ≥ 40 years has an electrocardiographic pattern associated with a higher risk of sudden death (Brugada syndrome, long QT, or short QT).

Design and rationale of a multicentre, randomised, double-blind, placebo-controlled clinical trial to evaluate the effect of vitamin D on ventricular remodelling in patients with anterior myocardial infarction: the VITamin D in Acute Myocardial Infarction (VITDAMI) trial.

INTRODUCTION: Decreased plasma vitamin D (VD) levels are linked to cardiovascular damage. However, clinical trials have not demonstrated a benefit of VD supplements on left ventricular (LV) remodelling. Anterior ST-elevation acute myocardial infarction (STEMI) is the best human model to study the effect of treatments on LV remodelling. We present a proof-of-concept study that aims to investigate whether VD improves LV remodelling in patients with anterior STEMI. METHODS AND ANALYSIS: The VITamin D in Acute Myocardial Infarction (VITDAMI) trial is a multicentre, randomised, double-blind, placebo-controlled trial. 144 patients with anterior STEMI will be assigned to receive calcifediol 0.266 mg capsules (Hidroferol SGC)/15 days or placebo on a 2:1 basis during 12 months. PRIMARY OBJECTIVE: to evaluate the effect of calcifediol on LV remodelling defined as an increase in LV end-diastolic volume ≥10% (MRI). SECONDARY OBJECTIVES: change in LV end-diastolic and end-systolic volumes, ejection fraction, LV mass, diastolic function, sphericity index and size of fibrotic area; endothelial function; plasma levels of aminoterminal fragment of B-type natriuretic peptide, galectin-3 and monocyte chemoattractant protein-1; levels of calcidiol (VD metabolite) and other components of mineral metabolism (fibroblast growth factor-23 (FGF-23), the soluble form of its receptor klotho, parathormone and phosphate). Differences in the effect of VD will be investigated according to the plasma levels of FGF-23 and klotho. Treatment safety and tolerability will be assessed. This is the first study to evaluate the effect of VD on cardiac remodelling in patients with STEMI. ETHICS AND DISSEMINATION: This trial has been approved by the corresponding Institutional Review Board (IRB) and National Competent Authority (Agencia Española de Medicamentos y Productos Sanitarios (AEMPS)). It will be conducted in accordance with good clinical practice (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use - Good Clinical Practice (ICH-GCP)) requirements, ethical principles of the Declaration of Helsinki and national laws. The results will be submitted to indexed medical journals and national and international meetings. TRIAL REGISTRATION NUMBER: NCT02548364; Pre-results.