Original article
Status of cardiac resynchronization therapy in Catalonia, Spain: Results of the prospective multicentric study TRC-CAT
Estado actual del tratamiento de resincronización cardiaca en Cataluña: resultados del estudio prospectivo multicéntrico TRC-CAT
María Emilce Truccoa, José María Tolosanaa,
, Elena Arbeloa, Francisco Javier Méndezb, Xavier Viñolasb, Ignasi Anguerac, Paolo Dallaglioc, Roger Villuendasd, Damià Pereferrer Kleinerd, Jordi Pérez-Rodone, Ivo Roca-Luquee, Jordi Mercéf, Alfredo Badarjíf, Julio Martí Almorg, Ermengol Vallésg, Antonio Berruezoa, Marta Sitgesa, Josep Brugadaa, Lluis Monta
Corresponding author
a Hospital Clínic, Universitat de Barcelona, Barcelona, Spain
b Hospital de la Santa Creu i Sant Pau, Barcelona, Spain
c Hospital Universitari de Bellvitge, L’Hospitalet de Llobregat, Barcelona, Spain
d Hospital Germans Trias i Pujol, Badalona, Barcelona, Spain
e Hospital Universitari Vall d’Hebron, Barcelona, Spain
f Hospital Universitari de Tarragona Joan XXIII, Tarragona, Spain
g Hospital del Mar, Barcelona, Spain
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"<span class="elsevierStyleSup">a</span>" "identificador" => "aff0005" ] ] ] 17 => array:3 [ "nombre" => "Josep" "apellidos" => "Brugada" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">a</span>" "identificador" => "aff0005" ] ] ] 18 => array:3 [ "nombre" => "Lluis" "apellidos" => "Mont" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">a</span>" "identificador" => "aff0005" ] ] ] ] "afiliaciones" => array:7 [ 0 => array:3 [ "entidad" => "Hospital Clínic, Universitat de Barcelona, Barcelona, Spain" "etiqueta" => "a" "identificador" => "aff0005" ] 1 => array:3 [ "entidad" => "Hospital de la Santa Creu i Sant Pau, Barcelona, Spain" "etiqueta" => "b" "identificador" => "aff0010" ] 2 => array:3 [ "entidad" => "Hospital Universitari de Bellvitge, L’Hospitalet de Llobregat, Barcelona, Spain" "etiqueta" => "c" "identificador" => "aff0015" ] 3 => array:3 [ "entidad" => "Hospital Germans Trias i Pujol, Badalona, Barcelona, Spain" "etiqueta" => "d" "identificador" => "aff0020" ] 4 => array:3 [ "entidad" => "Hospital Universitari Vall d’Hebron, Barcelona, Spain" "etiqueta" => "e" "identificador" => "aff0025" ] 5 => array:3 [ "entidad" => "Hospital Universitari de Tarragona Joan XXIII, Tarragona, Spain" "etiqueta" => "f" "identificador" => "aff0030" ] 6 => array:3 [ "entidad" => "Hospital del Mar, Barcelona, Spain" "etiqueta" => "g" "identificador" => "aff0035" ] ] "correspondencia" => array:1 [ 0 => array:3 [ "identificador" => "cor0005" "etiqueta" => "⁎" "correspondencia" => "Corresponding author." ] ] ] ] "titulosAlternativos" => array:1 [ "es" => array:1 [ "titulo" => "Estado actual del tratamiento de resincronización cardiaca en Cataluña: resultados del estudio prospectivo multicéntrico TRC-CAT" ] ] "resumenGrafico" => array:2 [ "original" => 0 "multimedia" => array:7 [ "identificador" => "fig0010" "etiqueta" => "Fig. 2" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr2.jpeg" "Alto" => 1397 "Ancho" => 1361 "Tamanyo" => 65848 ] ] "descripcion" => array:1 [ "en" => "<p id="spar0050" class="elsevierStyleSimplePara elsevierViewall">Hospitalizations for heart failure during pre- and post-implantation periods.</p>" ] ] ] "textoCompleto" => "<span class="elsevierStyleSections"><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0065">Introduction</span><p id="par0005" class="elsevierStylePara elsevierViewall">Heart failure (HF) is the third leading cause of death from cardiovascular disease in Spain, causing 25% of deaths.<a class="elsevierStyleCrossRef" href="#bib0125"><span class="elsevierStyleSup">1</span></a> Cardiac resynchronization therapy (CRT) is an option in the treatment of heart failure when the drug regimen is insufficient. Numerous clinical trials have shown the benefit of this treatment.<a class="elsevierStyleCrossRefs" href="#bib0130"><span class="elsevierStyleSup">2–5</span></a></p><p id="par0010" class="elsevierStylePara elsevierViewall">From an economic point of view and in developed countries, health resources dedicated to HF represent between 1% and 2% of global health spending. These costs are increased according to the severity of the disease and the degree of ventricular dysfunction. CRT has shown to significantly reduce the number of admissions for decompensation and the total number of hospital days in several randomized studies. Therefore, CRT could not only improve morbidity and mortality, but also save financial resources.<a class="elsevierStyleCrossRefs" href="#bib0150"><span class="elsevierStyleSup">6–8</span></a></p><p id="par0015" class="elsevierStylePara elsevierViewall">Clinical trials, however, are designed to assess the response of therapeutic interventions, but usually exclude patients with different comorbidities and poor prognosis, and this can lead to an unrealistic view of clinical practice. On the other hand, most surveys include more heterogeneous patients, although these are selectively included. This often involves a patient selection bias and inadequate data collection.<a class="elsevierStyleCrossRefs" href="#bib0165"><span class="elsevierStyleSup">9–11</span></a> The inclusion of consecutive patients in a prospective multicenter study eliminates selection bias and ensures greater reliability.</p><p id="par0020" class="elsevierStylePara elsevierViewall">The aim of the study was to analyze CRT efficacy in terms of clinical improvement and echocardiographic remodelling, and the safety of this treatment assessed by patient mortality and complications in Catalonia.</p></span><span id="sec0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0070">Methods</span><p id="par0025" class="elsevierStylePara elsevierViewall">A cohort of consecutive patients who underwent a primary implantation of a CRT device in 7 university hospitals in Catalonia, which account for 90% of patients undergoing CRT in this region, were prospectively analyzed.</p><p id="par0030" class="elsevierStylePara elsevierViewall">A joint and sole data base was developed for all implant sites involved in the study. The study was coordinated by an external <span class="elsevierStyleItalic">Clinical Research Organization</span> (Anagram-ESIC), which ensured proper compliance with the rules and the proper collection and analysis of results.</p><p id="par0035" class="elsevierStylePara elsevierViewall">All patients who underwent CRT within a year at these sites were included in the study. The follow-up was extended for a year after implantation; the inclusion criteria, clinical data, device interrogation and ancillary tests (ECG, echocardiogram, 6-min walk test and quality of life questionnaire) were collected. Clinical and echocardiographic results together with survival data were analyzed at 6 and 12 months after implantation.</p><span id="sec0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0075">Inclusion criteria</span><p id="par0040" class="elsevierStylePara elsevierViewall">All patients who were successfully implanted a CRT device in the public hospital network participating in the study, representing >90% of CRT device implants in Catalonia.</p></span><span id="sec0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0080">Exclusion criteria</span><p id="par0045" class="elsevierStylePara elsevierViewall">Patients with unstable heart disease, active infection or minors. Subjects who refused to sign the informed consent to participate in the study.</p></span><span id="sec0025" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0085">Implant and device programming</span><p id="par0050" class="elsevierStylePara elsevierViewall">The right ventricular (RV) electrode was positioned at the apex of the RV, at the discretion of the implanter. The atrial electrode was implanted in the septal region or the right atrial appendage. The electrode of the left ventricle (LV) was introduced through the coronary sinus in a lateral vein whenever possible. If the LV electrode could not be placed successfully, the implantation was performed via epicardial access through a mini-thoracotomy.</p><p id="par0055" class="elsevierStylePara elsevierViewall">Patients in sinus rhythm were programmed in DDD or DDDR mode in case of sinus node dysfunction. The minimum heart rate was 50<span class="elsevierStyleHsp" style=""></span>lpm. Patients with atrial fibrillation were programmed in VVIR mode at 70–75<span class="elsevierStyleHsp" style=""></span>lpm and maximum heart rate was set at 85% of the theoretical maximum heart rate. Individualized measures were taken in order to obtain a biventricular pacing target close to 100% in all patients.</p></span><span id="sec0030" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0090">Echocardiographic assessment</span><p id="par0060" class="elsevierStylePara elsevierViewall">Two-dimensional echocardiography was performed with the patient in lateral decubitus position. M-mode standard images and two-dimensional images were obtained. LV volume and LV ejection fraction (LVEF) were calculated by the Simpson method in 2 and 4 cameras. The presence of mitral regurgitation was recorded systematically. Colour Doppler echocardiography was performed on all views after gain and Nyquist limit optimization.</p><p id="par0065" class="elsevierStylePara elsevierViewall">Any improvement of at least 5 points of LVEF at 12 months after implantation in living patients and without requiring heart transplantation was defined as reverse echocardiographic remodelling.<a class="elsevierStyleCrossRef" href="#bib0180"><span class="elsevierStyleSup">12</span></a></p></span><span id="sec0035" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0095">Measurements of clinical episodes</span><p id="par0070" class="elsevierStylePara elsevierViewall">All patients underwent a 12-lead ECG, an echocardiogram and a clinical assessment prior to implantation and at 6 and 12 months’ post-implant. Patients were seen in the outpatient clinic every 6 months and, in addition, every time an examination was required due to a worsening of their clinical condition. Where available, patients were assessed with a quality of life test and a 6-min walk test, obtained at baseline and at 6 and 12 months after implantation.</p><p id="par0075" class="elsevierStylePara elsevierViewall">A patient who was alive at 12 months after implantation, had not required a heart transplant and had improved ≥10% of the distance covered in the baseline 6-min walk test or had improved ≥one stage of functional class if the previously mentioned test was not available, was defined as clinical responder.</p><p id="par0080" class="elsevierStylePara elsevierViewall">Drug treatment was recorded and adjusted in outpatient care. Complications, hospital admissions for cardiac decompensation and adverse events were also recorded. Early complication was defined as the one occurring during the first 48<span class="elsevierStyleHsp" style=""></span>h post-implant, and late complication as the one occurring during the first 30 days after implantation.</p><p id="par0085" class="elsevierStylePara elsevierViewall">Mortality data were collected and reviewed in medical records or by telephone interview with family members. Deaths were categorized into cardiac, noncardiac, or unknown cause. Cardiac deaths were classified as sudden (not preceded by HF or ischaemic symptoms) or due to HF; when the cause of death could not be determined it was classified as unknown.<a class="elsevierStyleCrossRef" href="#bib0185"><span class="elsevierStyleSup">13</span></a></p></span><span id="sec0040" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0100">Costs and consumption of health resources</span><p id="par0090" class="elsevierStylePara elsevierViewall">The cost of the implant was established from the consumption of resources (implanted devices, length of stay associated with the implant and unit costs) and associated costs. The average cost per patient was calculated. The number of hospital admissions during the pre-implantation and post-implantation year was calculated using a McNemar test or a Bowker symmetry test, depending on the range of distributions of the number of pre- and post-implantation admissions.</p></span><span id="sec0045" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0105">Statistic analysis</span><p id="par0095" class="elsevierStylePara elsevierViewall">Continuous variables are presented as the mean value<span class="elsevierStyleHsp" style=""></span>±<span class="elsevierStyleHsp" style=""></span>standard deviation. The Mann–Whitney test was used to compare these variables. Categorical variables were expressed as total number and percentages. Event-free survival was assessed by the Kaplan–Meier method. The effect of different variables in event-free survival was investigated using the Cox proportional hazards model. A value of <span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span><<span class="elsevierStyleHsp" style=""></span>0.10 was used to assess the covariates. The relative risk and confidence interval of 95% were calculated. For all, a value of <span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span><<span class="elsevierStyleHsp" style=""></span>0.05 was considered statistically significant. Statistical analysis was performed using R <span class="elsevierStyleItalic">software</span> for Windows version 3.0.2 (R Project for Statistical Computing, Vienna, Austria).</p></span></span><span id="sec0050" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0110">Results</span><p id="par0100" class="elsevierStylePara elsevierViewall">A cohort of 200 consecutive patients who were implanted a cardiac resynchronization device during a year in 7 university hospitals in Catalonia was analyzed. More than 50% of the implants were performed on 2 of the 7 implant sites participating in the study. The profile and baseline characteristics of our patients are shown in <a class="elsevierStyleCrossRef" href="#tbl0005">Table 1</a>.</p><elsevierMultimedia ident="tbl0005"></elsevierMultimedia><p id="par0105" class="elsevierStylePara elsevierViewall">The registry also reflected an adequate selection of candidates for CRT, since in 199 out of 200 cases (99%) the recommendations made by current European guidelines were followed.<a class="elsevierStyleCrossRef" href="#bib0190"><span class="elsevierStyleSup">14</span></a></p><p id="par0110" class="elsevierStylePara elsevierViewall">Of the 200 patients included in the registry, 136 (68%) received CRT with implantable cardioverter defibrillator (ICD) (CRT-D) and 64 (32%) CRT with pacemaker (CRT-P). Most CRT-D were implanted for primary prevention (111/136; 82%) and 25 (18%) for secondary prevention. Forty-two (21%) patients were already carriers of a previously implanted pacemaker or a conventional ICD and underwent an <span class="elsevierStyleItalic">Up-grade</span> to a CRT device due to HF signs and symptoms.</p><p id="par0115" class="elsevierStylePara elsevierViewall">Transvenous electrode placement in the coronary sinus could not be achieved in 10 patients (5%). The reasons for these were coronary sinus cannulation failure in 6 (3%) patients and poor coronary venous anatomy (0.5%), vena cava malformation (0.5%), electrode displacement (0, 5%) and subclavian vein thrombosis (0.5%) in one patient each. In all of these a surgical epicardial implant approach was implemented.</p><p id="par0120" class="elsevierStylePara elsevierViewall">The average implant time was 150<span class="elsevierStyleHsp" style=""></span>min (Q1 90<span class="elsevierStyleHsp" style=""></span>min–Q3 180<span class="elsevierStyleHsp" style=""></span><span class="elsevierStyleHsp" style=""></span>min). The fluoroscopy time was 15<span class="elsevierStyleHsp" style=""></span>min (Q1 9<span class="elsevierStyleHsp" style=""></span>min–Q3 27 <span class="elsevierStyleHsp" style=""></span>min). Following implantation, 152 patients (76%) were optimized seeking the narrowest QRS, 7 by echocardiography, 6 by the device's algorithm and, in 35 patients (17%), the device was programmed according to the nominal parameters of the manufacturer.</p><p id="par0125" class="elsevierStylePara elsevierViewall">Among the survivors, the percentage of ventricular pacing at 12 months was 98%. In 27 patients (13.5%) a pacing percentage<span class="elsevierStyleHsp" style=""></span>≤<span class="elsevierStyleHsp" style=""></span>92% was observed.</p><span id="sec0055" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0115">Complications and mortality</span><p id="par0130" class="elsevierStylePara elsevierViewall">The early complication rate was 13% (26 patients) and <a class="elsevierStyleCrossRef" href="#tbl0010">Table 2</a> shows the different types. Most of these complications were related to electrode displacement (7; 3.5%) or with the procedure, such as the presence of haematoma (6; 3%) or pneumothorax (2; 1%). In addition, during this early phase (up to 48<span class="elsevierStyleHsp" style=""></span>h post implant) 3 patients had cardiac decompensation and one patient had a cerebral ischaemic attack.</p><elsevierMultimedia ident="tbl0010"></elsevierMultimedia><p id="par0135" class="elsevierStylePara elsevierViewall">During follow-up, the LV electrode was repositioned in 6 patients (3%) due to loss of capture. 5 device infections (2.5%) were detected, which forced explantation and re-implantation after completing antibiotic treatment.</p><p id="par0140" class="elsevierStylePara elsevierViewall">16 patients died during follow-up (8%) and there were no cardiac transplantations. Just 5 (2.5%) patients died from cardiac causes; the rest of deaths (11; 5.5%) were due to other non-cardiac reasons.</p></span><span id="sec0060" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0120">Clinical and echocardiographic improvement during follow-up</span><p id="par0145" class="elsevierStylePara elsevierViewall">During follow-up, a high percentage of survivors experienced an improvement of at least one point in functional class. Before the implant, 66 patients (33%) had a HF functional class of <span class="elsevierStyleSmallCaps">i–ii</span> of the <span class="elsevierStyleItalic">New York Heart Association</span> (NYHA), and the rest (134; 66%) had a HF functional class of <span class="elsevierStyleSmallCaps">iii–iv</span>. At 6 months after implantation, three-quarters of patients (149/200; 74%) went on to have an HF functional class of <span class="elsevierStyleSmallCaps">i–ii</span> according to NYHA and this percentage remained at 12 months after implantation in 157/200 (78%) (<span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span><<span class="elsevierStyleHsp" style=""></span>0.0001) (<a class="elsevierStyleCrossRef" href="#fig0005">Fig. 1</a>).</p><elsevierMultimedia ident="fig0005"></elsevierMultimedia><p id="par0150" class="elsevierStylePara elsevierViewall">After implantation, the percentage of clinical responders was 53% at 6 months and 56% at 12 months. An improvement was observed in the 120 patients (60%) who underwent the 6-min walk test, going from an average baseline test distance of 343<span class="elsevierStyleHsp" style=""></span>±<span class="elsevierStyleHsp" style=""></span>100 to 403<span class="elsevierStyleHsp" style=""></span>±<span class="elsevierStyleHsp" style=""></span>90<span class="elsevierStyleHsp" style=""></span>m at 12 months after implantation (<span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span><<span class="elsevierStyleHsp" style=""></span>0.0001).</p><p id="par0155" class="elsevierStylePara elsevierViewall">There has also been an improvement in the quality of life among survivors at 12 months after implantation (measured by the Minnesota test). The Minnesota test scores went from 43<span class="elsevierStyleHsp" style=""></span>±<span class="elsevierStyleHsp" style=""></span>22 (prior to implant) to 26<span class="elsevierStyleHsp" style=""></span>±<span class="elsevierStyleHsp" style=""></span>21 points (<span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span><<span class="elsevierStyleHsp" style=""></span>0.001).</p><p id="par0160" class="elsevierStylePara elsevierViewall">End-diastolic LV (LVEDV) and end-systolic LV (LVESV) volumes decreased progressively among CRT survivors, moving from a baseline LVEDV of 191<span class="elsevierStyleHsp" style=""></span>±<span class="elsevierStyleHsp" style=""></span>72 to 158<span class="elsevierStyleHsp" style=""></span>±<span class="elsevierStyleHsp" style=""></span>65<span class="elsevierStyleHsp" style=""></span>cc and from a baseline LVESV of 142<span class="elsevierStyleHsp" style=""></span>±<span class="elsevierStyleHsp" style=""></span>61 to 104<span class="elsevierStyleHsp" style=""></span>±<span class="elsevierStyleHsp" style=""></span>56<span class="elsevierStyleHsp" style=""></span>cc, respectively, at 12 months after implantation. The reverse remodelling produced by the CRT caused a significant improvement of LVEF. The mean baseline LVEF in patients enrolled was 26<span class="elsevierStyleHsp" style=""></span>±<span class="elsevierStyleHsp" style=""></span>8%, and it increased to 36<span class="elsevierStyleHsp" style=""></span>±<span class="elsevierStyleHsp" style=""></span>12% at 12 months of the study (<span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span><<span class="elsevierStyleHsp" style=""></span>0.0001). Of the patients enrolled, 124 (62%) showed an improvement of at least 5 points from baseline LVEF, being considered echocardiographic responders to CRT.</p></span><span id="sec0065" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0125">Hospitalizations and resource consumption analysis</span><p id="par0165" class="elsevierStylePara elsevierViewall">During the cardiac resynchronization device preimplantation year, 92 (46%) patients were admitted for decompensated heart disease, requiring a total of 150 hospital admissions. Of these 92 patients, 59 (64.2%) required one admission, 17 (18.4%) two admissions and 16 (17.4%) three or more admissions.</p><p id="par0170" class="elsevierStylePara elsevierViewall">The year after cardiac resynchronization device implantation, the number of patients requiring hospitalization dropped to 14 (7%), with a total of 27 hospital admissions. Of these 14 patients, 6 (43%) required one admission, 4 (28.5%) two admissions, 3 (21%) three admissions and 1 (7%) four admissions.</p><p id="par0175" class="elsevierStylePara elsevierViewall">Compared to the year prior to device implantation, CRT decreased by 82% the number of hospital admissions. This results in a statistically significant difference when comparing the pre- and post-implantation periods (McNemar chi-squared <span class="elsevierStyleHsp" style=""></span>=<span class="elsevierStyleHsp" style=""></span>73.2; <span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span><<span class="elsevierStyleHsp" style=""></span>0.001) (<a class="elsevierStyleCrossRef" href="#fig0010">Fig. 2</a>).</p><elsevierMultimedia ident="fig0010"></elsevierMultimedia><p id="par0180" class="elsevierStylePara elsevierViewall">The direct costs estimated by the sum of the admission costs (valued at 319<span class="elsevierStyleHsp" style=""></span>€/day) and the cost of the implanted device (valued at 4014<span class="elsevierStyleHsp" style=""></span>€/pacemakers and 15,840<span class="elsevierStyleHsp" style=""></span>€/defibrillator) ranged from 4.333<span class="elsevierStyleHsp" style=""></span>€ and 39,974<span class="elsevierStyleHsp" style=""></span>€, with an average of 14,460<span class="elsevierStyleHsp" style=""></span>€ (95% CI 13,541–15,380).</p></span></span><span id="sec0070" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0130">Discussion</span><p id="par0185" class="elsevierStylePara elsevierViewall">This multicenter regional study on CRT has included 90% of patients implanted in a region, thus avoiding selection bias and providing high-quality and reliable data about the current clinical reality of resynchronization in a particular region. This allows knowing the CRT status in Catalonia, allowing to monitor the local situation in comparison with data from the literature. The enrolment of patients was done consecutively and one-year follow-up was sufficient to assess complications, efficacy and reduced hospitalizations due to this therapeutic tool.</p><span id="sec0075" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0135">Implants and selection of candidates for cardiac resynchronization therapy</span><p id="par0190" class="elsevierStylePara elsevierViewall">International guidelines have clearly set the indication of CRT<a class="elsevierStyleCrossRef" href="#bib0190"><span class="elsevierStyleSup">14</span></a> and our study confirms the correct selection of patients, demonstrating good adherence to the current indications.</p><p id="par0195" class="elsevierStylePara elsevierViewall">Unlike the European register published in 2011,<a class="elsevierStyleCrossRef" href="#bib0195"><span class="elsevierStyleSup">15</span></a> in which the percentage of patients in NYHA functional class II was 20%, in our study, this percentage reaches 33%. On the other hand, in our study, the percentage of patients in NYHA class <span class="elsevierStyleSmallCaps">IV</span>was only 4.5%, while, in the European register, it was close to 9%. Possibly, the publication of various clinical trials<a class="elsevierStyleCrossRefs" href="#bib0200"><span class="elsevierStyleSup">16–18</span></a> demonstrating the efficacy of CRT in patients with mild HF has resulted in having a higher percentage of these patients in our study, reflecting the trend of starting CRT early, avoiding possible device implantation in patients with more advanced disease.</p><p id="par0200" class="elsevierStylePara elsevierViewall">However, there are no differences when compared to other epidemiological characteristics, with a prevalence of male patients with LVEF<span class="elsevierStyleHsp" style=""></span><<span class="elsevierStyleHsp" style=""></span>30% and QRS<span class="elsevierStyleHsp" style=""></span>><span class="elsevierStyleHsp" style=""></span>150<span class="elsevierStyleHsp" style=""></span>ms, and patients with atrial fibrillation reaching up to 25% of the sample.</p><p id="par0205" class="elsevierStylePara elsevierViewall">Spanish records for pacemakers<a class="elsevierStyleCrossRef" href="#bib0215"><span class="elsevierStyleSup">19</span></a> and defibrillators<a class="elsevierStyleCrossRef" href="#bib0220"><span class="elsevierStyleSup">20</span></a> describe a stagnation in growth in the number of implants in Spain in recent years, with significant regional differences, within the country, and international, with respect to other European countries, being below the European average according to EUCOMED data.<a class="elsevierStyleCrossRef" href="#bib0225"><span class="elsevierStyleSup">21</span></a> In 2013 the total implant incidence of cardiac resynchronization devices (including primary implantations and replacements) in Europe was 113 devices/million inhabitants-year and Spain reached 58 devices/million inhabitants-year.<a class="elsevierStyleCrossRef" href="#bib0225"><span class="elsevierStyleSup">21</span></a> In our territory, calculating a population of 7,500,000 inhabitants, when we speak of primary implantations the incidence of these was only 29/million inhabitants.<a class="elsevierStyleCrossRef" href="#bib0230"><span class="elsevierStyleSup">22</span></a> The prevalence of cardiovascular disease, access and organization of the healthcare reimbursement system and the degree of knowledge and monitoring of clinical guidelines could be related to the low rate of primary implantation.</p></span><span id="sec0080" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0140">Implant-related complications</span><p id="par0210" class="elsevierStylePara elsevierViewall">Despite the low rate of implants compared to other regions,<a class="elsevierStyleCrossRef" href="#bib0225"><span class="elsevierStyleSup">21</span></a> the rate of early and late complications was similar to those previously published.<a class="elsevierStyleCrossRef" href="#bib0235"><span class="elsevierStyleSup">23</span></a> This shows that the implantation of devices in our territory is being performed safely, with a rate of complications similar to those published in the medical literature.</p><p id="par0215" class="elsevierStylePara elsevierViewall">During the follow-up period, and unlike other records,<a class="elsevierStyleCrossRefs" href="#bib0215"><span class="elsevierStyleSup">19,20,23</span></a> not only early complications were registered, but also late ones. The most frequent early complication was electrode displacement, which, in turn, was the main cause of reoperation.</p></span><span id="sec0085" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0145">Clinical improvement and hospital admissions</span><p id="par0220" class="elsevierStylePara elsevierViewall">The percentage of hospital admissions during the first year was only 8%, lower than the figure recorded in the European register,<a class="elsevierStyleCrossRef" href="#bib0235"><span class="elsevierStyleSup">23</span></a> which reached 16%. Possibly, as a higher percentage of patients with mild HF, NYHA functional class <span class="elsevierStyleSmallCaps">ii</span> have been included in this study, this has favoured the low rate of hospital admissions obtained in our record.</p><p id="par0225" class="elsevierStylePara elsevierViewall">During the first 12 months after implantation, CRT had a clear clinical and echocardiographic response in patients, improving NYHA functional class, functional capacity and quality of life. Moreover, it was accompanied by a reverse remodelling with a decrease in heart size and an improvement in LVEF, since up to 62% of patients improved the baseline ejection fraction by at least 5 absolute points. In this case, our data are consistent with previous studies which demonstrated that the impact of CRT in heart failure in terms of clinical improvement is lower for patients in functional class II than those in III or IV.<a class="elsevierStyleCrossRef" href="#bib0240"><span class="elsevierStyleSup">24</span></a></p><p id="par0230" class="elsevierStylePara elsevierViewall">This clinical and echocardiographic improvement led to an 82% decrease in the number of hospital admissions, so resynchronization significantly decreased spending derived from hospital stays and home care for patients with HF. In addition, a low cardiac mortality was observed. A cost-effectiveness analysis could establish in more detail the benefits of this treatment.</p></span><span id="sec0090" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0150">Limitations</span><p id="par0235" class="elsevierStylePara elsevierViewall">The sample size is small, so the mortality figures and the results have limited reliability. However, the small sample size has allowed a complete and comprehensive follow-up. On the other hand, the policy to concentrate most implants in just a few sites means that the results are applicable to university centres of excellence, which would not be possible if widespread implantation had taken place, in many centres and with a low number of implants by site and implanter.</p></span></span><span id="sec0095" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0155">Conclusions</span><p id="par0240" class="elsevierStylePara elsevierViewall">In an unselected population of Catalonia, we observed similar CRT efficacy results with lower hospitalization rates compared to European records.</p><p id="par0245" class="elsevierStylePara elsevierViewall">CRT significantly reduces hospital admissions, resulting in clinical improvement and reverse echocardiographic remodelling, which seems to justify the economic costs of this treatment.</p></span><span id="sec0100" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0160">Conflict of interests</span><p id="par0250" class="elsevierStylePara elsevierViewall">The authors declare no conflict of interest.</p></span></span>" "textoCompletoSecciones" => array:1 [ "secciones" => array:12 [ 0 => array:3 [ "identificador" => "xres729239" "titulo" => "Abstract" "secciones" => array:4 [ 0 => array:2 [ "identificador" => "abst0005" "titulo" => "Introduction and objectives" ] 1 => array:2 [ "identificador" => "abst0010" "titulo" => "Methods" ] 2 => array:2 [ "identificador" => "abst0015" "titulo" => "Results" ] 3 => array:2 [ "identificador" => "abst0020" "titulo" => "Conclusions" ] ] ] 1 => array:2 [ "identificador" => "xpalclavsec733301" "titulo" => "Keywords" ] 2 => array:3 [ "identificador" => "xres729238" "titulo" => "Resumen" "secciones" => array:4 [ 0 => array:2 [ "identificador" => "abst0025" "titulo" => "Introducción y objetivos" ] 1 => array:2 [ "identificador" => "abst0030" "titulo" => "Métodos" ] 2 => array:2 [ "identificador" => "abst0035" "titulo" => "Resultados" ] 3 => array:2 [ "identificador" => "abst0040" "titulo" => "Conclusiones" ] ] ] 3 => array:2 [ "identificador" => "xpalclavsec733302" "titulo" => "Palabras clave" ] 4 => array:2 [ "identificador" => "sec0005" "titulo" => "Introduction" ] 5 => array:3 [ "identificador" => "sec0010" "titulo" => "Methods" "secciones" => array:7 [ 0 => array:2 [ "identificador" => "sec0015" "titulo" => "Inclusion criteria" ] 1 => array:2 [ "identificador" => "sec0020" "titulo" => "Exclusion criteria" ] 2 => array:2 [ "identificador" => "sec0025" "titulo" => "Implant and device programming" ] 3 => array:2 [ "identificador" => "sec0030" "titulo" => "Echocardiographic assessment" ] 4 => array:2 [ "identificador" => "sec0035" "titulo" => "Measurements of clinical episodes" ] 5 => array:2 [ "identificador" => "sec0040" "titulo" => "Costs and consumption of health resources" ] 6 => array:2 [ "identificador" => "sec0045" "titulo" => "Statistic analysis" ] ] ] 6 => array:3 [ "identificador" => "sec0050" "titulo" => "Results" "secciones" => array:3 [ 0 => array:2 [ "identificador" => "sec0055" "titulo" => "Complications and mortality" ] 1 => array:2 [ "identificador" => "sec0060" "titulo" => "Clinical and echocardiographic improvement during follow-up" ] 2 => array:2 [ "identificador" => "sec0065" "titulo" => "Hospitalizations and resource consumption analysis" ] ] ] 7 => array:3 [ "identificador" => "sec0070" "titulo" => "Discussion" "secciones" => array:4 [ 0 => array:2 [ "identificador" => "sec0075" "titulo" => "Implants and selection of candidates for cardiac resynchronization therapy" ] 1 => array:2 [ "identificador" => "sec0080" "titulo" => "Implant-related complications" ] 2 => array:2 [ "identificador" => "sec0085" "titulo" => "Clinical improvement and hospital admissions" ] 3 => array:2 [ "identificador" => "sec0090" "titulo" => "Limitations" ] ] ] 8 => array:2 [ "identificador" => "sec0095" "titulo" => "Conclusions" ] 9 => array:2 [ "identificador" => "sec0100" "titulo" => "Conflict of interests" ] 10 => array:2 [ "identificador" => "xack242350" "titulo" => "Acknowledgement" ] 11 => array:1 [ "titulo" => "References" ] ] ] "pdfFichero" => "main.pdf" "tienePdf" => true "fechaRecibido" => "2015-08-31" "fechaAceptado" => "2015-11-05" "PalabrasClave" => array:2 [ "en" => array:1 [ 0 => array:4 [ "clase" => "keyword" "titulo" => "Keywords" "identificador" => "xpalclavsec733301" "palabras" => array:3 [ 0 => "Cardiac resynchronization" 1 => "Mortality" 2 => "Hospital admissions" ] ] ] "es" => array:1 [ 0 => array:4 [ "clase" => "keyword" "titulo" => "Palabras clave" "identificador" => "xpalclavsec733302" "palabras" => array:3 [ 0 => "Resincronización cardiaca" 1 => "Mortalidad" 2 => "Hospitalizaciones" ] ] ] ] "tieneResumen" => true "resumen" => array:2 [ "en" => array:3 [ "titulo" => "Abstract" "resumen" => "<span id="abst0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0010">Introduction and objectives</span><p id="spar0005" class="elsevierStyleSimplePara elsevierViewall">Results of cardiac resynchronization therapy (CRT) have been extensively published. However, there is limited data in unselected populations. The objective of the study was to analyze the efficacy and safety of CRT in Catalonia.</p></span> <span id="abst0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0015">Methods</span><p id="spar0010" class="elsevierStyleSimplePara elsevierViewall">A prospective study was performed of consecutive patients implanted with CRT over one year in 7 university hospitals in Catalonia, representing 90% of the implanted patients. Echocardiographic reverse remodelling was defined as 5 points improvement in left ventricular ejection fraction and clinical responders were defined as patients with an increase >10% of 6-min walk test or one point of New York Heart Association functional class at 12 months. Patients were followed up for one year and hospital admissions and mortality were analyzed.</p></span> <span id="abst0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0020">Results</span><p id="spar0015" class="elsevierStyleSimplePara elsevierViewall">Of the 200 patients included in the study, 99% met the indications of the current CRT clinical guidelines and 68% received CRT with implantable cardioverter-defibrillator. The rate of complications was 12.5%. During follow-up 16 patients (8%) died. Fifty-two percent (104) of the population was considered to respond clinically and 62% (124) presented improved echocardiographic parameters. Compared to the year prior to implant, hospital admissions decreased by 82% (<span class="elsevierStyleItalic">P</span><span class="elsevierStyleHsp" style=""></span><<span class="elsevierStyleHsp" style=""></span>.001).</p></span> <span id="abst0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0025">Conclusions</span><p id="spar0020" class="elsevierStyleSimplePara elsevierViewall">In an unselected population of Catalonia, we observe that CRT was effective and decreased the number of hospital admissions.</p></span>" "secciones" => array:4 [ 0 => array:2 [ "identificador" => "abst0005" "titulo" => "Introduction and objectives" ] 1 => array:2 [ "identificador" => "abst0010" "titulo" => "Methods" ] 2 => array:2 [ "identificador" => "abst0015" "titulo" => "Results" ] 3 => array:2 [ "identificador" => "abst0020" "titulo" => "Conclusions" ] ] ] "es" => array:3 [ "titulo" => "Resumen" "resumen" => "<span id="abst0025" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0035">Introducción y objetivos</span><p id="spar0025" class="elsevierStyleSimplePara elsevierViewall">Los resultados del tratamiento de resincronización cardiaca (TRC) han sido extensamente publicados. Sin embargo, hay datos limitados en poblaciones no seleccionadas. El objetivo del estudio fue analizar la eficacia y la seguridad del TRC en Cataluña.</p></span> <span id="abst0030" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0040">Métodos</span><p id="spar0030" class="elsevierStyleSimplePara elsevierViewall">Se analizó prospectivamente una serie de pacientes consecutivos a los que se les implantó durante un año un dispositivo de TRC en 7 hospitales universitarios de Cataluña, los cuales representan el 90% del total de dispositivos implantados. Se definió como remodelado ecocardiográfico inverso el aumento de 5 puntos de la fracción de eyección del ventrículo izquierdo, y respondedores clínicos los pacientes que a los 12 meses habían aumentado<span class="elsevierStyleHsp" style=""></span>><span class="elsevierStyleHsp" style=""></span>10% la distancia recorrida en la prueba de caminar 6 minutos o un punto la clase de la <span class="elsevierStyleItalic">New York Heart Association</span>. El seguimiento de los pacientes fue por un año y se analizaron los ingresos hospitalarios y la mortalidad.</p></span> <span id="abst0035" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0045">Resultados</span><p id="spar0035" class="elsevierStyleSimplePara elsevierViewall">De los 200 pacientes incluidos en el estudio, el 99% cumplía las indicaciones de las guías clínicas actuales de TRC y el 68% recibió TRC con desfibrilador automático implantable. La tasa de complicaciones fue del 12.5%. Durante el seguimiento 16 pacientes (8%) murieron. El 52% (104) de la población fue respondedor clínico y un 62% (124) presentó remodelado ecocardiográfico. En comparación con el año previo al implante los ingresos hospitalarios se redujeron un 82%, lo que resultó en una diferencia estadísticamente significativa (p<span class="elsevierStyleHsp" style=""></span><<span class="elsevierStyleHsp" style=""></span>0,001).</p></span> <span id="abst0040" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0050">Conclusiones</span><p id="spar0040" class="elsevierStyleSimplePara elsevierViewall">En una población no seleccionada de Cataluña observamos que el TRC fue eficaz y redujo el número de hospitalizaciones.</p></span>" "secciones" => array:4 [ 0 => array:2 [ "identificador" => "abst0025" "titulo" => "Introducción y objetivos" ] 1 => array:2 [ "identificador" => "abst0030" "titulo" => "Métodos" ] 2 => array:2 [ "identificador" => "abst0035" "titulo" => "Resultados" ] 3 => array:2 [ "identificador" => "abst0040" "titulo" => "Conclusiones" ] ] ] ] "NotaPie" => array:1 [ 0 => array:2 [ "etiqueta" => "☆" "nota" => "<p class="elsevierStyleNotepara" id="npar0005">Please cite this article as: Trucco ME, Tolosana JM, Arbelo E, Méndez FJ, Viñolas X, Anguera I, et al. Estado actual del tratamiento de resincronización cardiaca en Cataluña: resultados del estudio prospectivo multicéntrico TRC-CAT. Med Clin (Barc). 2016;146:423–428.</p>" ] ] "multimedia" => array:4 [ 0 => array:7 [ "identificador" => "fig0005" "etiqueta" => "Fig. 1" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr1.jpeg" "Alto" => 1391 "Ancho" => 1519 "Tamanyo" => 80826 ] ] "descripcion" => array:1 [ "en" => "<p id="spar0045" class="elsevierStyleSimplePara elsevierViewall">Clinical improvement during 12-month follow-up.</p>" ] ] 1 => array:7 [ "identificador" => "fig0010" "etiqueta" => "Fig. 2" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr2.jpeg" "Alto" => 1397 "Ancho" => 1361 "Tamanyo" => 65848 ] ] "descripcion" => array:1 [ "en" => "<p id="spar0050" class="elsevierStyleSimplePara elsevierViewall">Hospitalizations for heart failure during pre- and post-implantation periods.</p>" ] ] 2 => array:8 [ "identificador" => "tbl0005" "etiqueta" => "Table 1" "tipo" => "MULTIMEDIATABLA" "mostrarFloat" => true "mostrarDisplay" => false "detalles" => array:1 [ 0 => array:3 [ "identificador" => "at1" "detalle" => "Table " "rol" => "short" ] ] "tabla" => array:2 [ "leyenda" => "<p id="spar0060" class="elsevierStyleSimplePara elsevierViewall">OAC, oral anticoagulants; ARBs, angiotensin II receptor blocker; CBRBHB, complete block of the right branch of the His bundle; NYHA FC, <span class="elsevierStyleItalic">New York Heart Association functional class</span>; LVEF, left ventricular ejection fraction; ACE inhibitors angiotensin-converting enzyme inhibitors; MR, mitral regurgitation; 6MWT, 6-min walk test; CRT-D, cardiac resynchronization therapy with implantable defibrillator; LVEDV, left ventricular end-diastolic volume; LVESV, left ventricular end-systolic volume.</p><p id="spar0065" class="elsevierStyleSimplePara elsevierViewall">Data are expressed as mean<span class="elsevierStyleHsp" style=""></span>±<span class="elsevierStyleHsp" style=""></span>standard deviation or n (percentage).</p>" "tablatextoimagen" => array:1 [ 0 => array:2 [ "tabla" => array:1 [ 0 => """ <table border="0" frame="\n \t\t\t\t\tvoid\n \t\t\t\t" class=""><tbody title="tbody"><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top"><span class="elsevierStyleItalic">Age (years)</span> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">65.7<span class="elsevierStyleHsp" style=""></span>±<span class="elsevierStyleHsp" style=""></span>9 \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top"><span class="elsevierStyleItalic">Sex (male)</span> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">157 (78) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top"><span class="elsevierStyleItalic">Ischaemic aetiology</span> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">73 (36.5) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top"><span class="elsevierStyleItalic">CBRBHB Morphology</span> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">160 (80) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top"><span class="elsevierStyleItalic">QRS duration (ms)</span> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">170<span class="elsevierStyleHsp" style=""></span>±<span class="elsevierStyleHsp" style=""></span>28 \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top"><span class="elsevierStyleItalic">Atrial fibrillation</span> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">49 (24.5) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top"><span class="elsevierStyleItalic">Complete AV block</span> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">22 (11) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top"><span class="elsevierStyleItalic">CRT-D</span> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">136 (68) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="table-entry " colspan="2" align="left" valign="top"><span class="elsevierStyleVsp" style="height:0.5px"></span></td></tr><tr title="table-row"><td class="td" title="table-entry " colspan="2" align="left" valign="top"><span class="elsevierStyleItalic">NYHA FC</span></td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top"><span class="elsevierStyleHsp" style=""></span>II \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">66 (33) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top"><span class="elsevierStyleHsp" style=""></span>III \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">124 (62) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top"><span class="elsevierStyleHsp" style=""></span>IV \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">9 (4.5) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="table-entry " colspan="2" align="left" valign="top"><span class="elsevierStyleVsp" style="height:0.5px"></span></td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top"><span class="elsevierStyleItalic">6MWT (m)</span> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">3438<span class="elsevierStyleHsp" style=""></span>±<span class="elsevierStyleHsp" style=""></span>103 \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top"><span class="elsevierStyleItalic">Minnesota Quality of Life Test (points)</span> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">43<span class="elsevierStyleHsp" style=""></span>±<span class="elsevierStyleHsp" style=""></span>23 \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top"><span class="elsevierStyleItalic">Creatinine (mg/dl)</span> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">1.3<span class="elsevierStyleHsp" style=""></span>±<span class="elsevierStyleHsp" style=""></span>0.9 \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top"><span class="elsevierStyleItalic">LVEDV (ml)</span> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">191<span class="elsevierStyleHsp" style=""></span>±<span class="elsevierStyleHsp" style=""></span>72 \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top"><span class="elsevierStyleItalic">LVESV (ml)</span> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">142<span class="elsevierStyleHsp" style=""></span>±<span class="elsevierStyleHsp" style=""></span>61 \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top"><span class="elsevierStyleItalic">LVEF (%)</span> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">27<span class="elsevierStyleHsp" style=""></span>±<span class="elsevierStyleHsp" style=""></span>8 \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top"><span class="elsevierStyleItalic">Severe MR</span> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">7 (3.5) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="table-entry " colspan="2" align="left" valign="top"><span class="elsevierStyleVsp" style="height:0.5px"></span></td></tr><tr title="table-row"><td class="td" title="table-entry " colspan="2" align="left" valign="top"><span class="elsevierStyleItalic">Medical treatment (n)</span></td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top"><span class="elsevierStyleHsp" style=""></span>Beta-blockers \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">167 (83) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top"><span class="elsevierStyleHsp" style=""></span>ACE inhibitors/ARBs \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">183 (92) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top"><span class="elsevierStyleHsp" style=""></span>Spironolactone \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">129 (65) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top"><span class="elsevierStyleHsp" style=""></span>Furosemide \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">172 (86) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top"><span class="elsevierStyleHsp" style=""></span>OAC \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">92 (46) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top"><span class="elsevierStyleHsp" style=""></span>Amiodarone \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">28 (14) \t\t\t\t\t\t\n \t\t\t\t</td></tr></tbody></table> """ ] "imagenFichero" => array:1 [ 0 => "xTab1201850.png" ] ] ] ] "descripcion" => array:1 [ "en" => "<p id="spar0055" class="elsevierStyleSimplePara elsevierViewall">Baseline characteristics of patients included in the study.</p>" ] ] 3 => array:8 [ "identificador" => "tbl0010" "etiqueta" => "Table 2" "tipo" => "MULTIMEDIATABLA" "mostrarFloat" => true "mostrarDisplay" => false "detalles" => array:1 [ 0 => array:3 [ "identificador" => "at2" "detalle" => "Table " "rol" => "short" ] ] "tabla" => array:2 [ "leyenda" => "<p id="spar0075" class="elsevierStyleSimplePara elsevierViewall">CVA, cardiovascular accident; HF, heart failure.</p>" "tablatextoimagen" => array:1 [ 0 => array:2 [ "tabla" => array:1 [ 0 => """ <table border="0" frame="\n \t\t\t\t\tvoid\n \t\t\t\t" class=""><thead title="thead"><tr title="table-row"><th class="td" title="table-head " align="" valign="top" scope="col" style="border-bottom: 2px solid black"> \t\t\t\t\t\t\n \t\t\t\t</th><th class="td" title="table-head " align="left" valign="top" scope="col" style="border-bottom: 2px solid black">n (%) \t\t\t\t\t\t\n \t\t\t\t</th></tr></thead><tbody title="tbody"><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top"><span class="elsevierStyleItalic">Early complications</span> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">26 (13) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="table-entry " colspan="2" align="left" valign="top"><span class="elsevierStyleVsp" style="height:0.5px"></span></td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top"><span class="elsevierStyleItalic">Electrode displacement</span> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">7 (3.5) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top"><span class="elsevierStyleHsp" style=""></span>Atrial \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">3 (1.5) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top"><span class="elsevierStyleHsp" style=""></span>Ventricular \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">4 (2) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="table-entry " colspan="2" align="left" valign="top"><span class="elsevierStyleVsp" style="height:0.5px"></span></td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top"><span class="elsevierStyleItalic">Haematoma</span> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">6 (3) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top"><span class="elsevierStyleItalic">Decompensated HF</span> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">3 (1.5) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top"><span class="elsevierStyleItalic">Phrenic pacing</span> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">3 (1.5) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top"><span class="elsevierStyleItalic">Pneumothorax</span> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">2 (1) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top"><span class="elsevierStyleItalic">Dissection of the coronary sinus</span> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">2 (1) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top"><span class="elsevierStyleItalic">CVA</span> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">1 (0.5) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top"><span class="elsevierStyleItalic">Kidney failure by contrast</span> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">1 (0.5) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top"><span class="elsevierStyleItalic">Phlebitis</span> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">1 (0.5) \t\t\t\t\t\t\n \t\t\t\t</td></tr></tbody></table> """ ] "imagenFichero" => array:1 [ 0 => "xTab1201851.png" ] ] ] ] "descripcion" => array:1 [ "en" => "<p id="spar0070" class="elsevierStyleSimplePara elsevierViewall">Early complications after implantation.</p>" ] ] ] "bibliografia" => array:2 [ "titulo" => "References" "seccion" => array:1 [ 0 => array:2 [ "identificador" => "bibs0005" "bibliografiaReferencia" => array:24 [ 0 => array:3 [ "identificador" => "bib0125" "etiqueta" => "1" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Epidemiología de la insuficiencia cardíaca" "autores" => array:1 [ 0 => array:2 [ "etal" => false "autores" => array:3 [ 0 => "F. 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