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    "textoCompleto" => "<span class="elsevierStyleSections"><p id="par0005" class="elsevierStylePara elsevierViewall">In 1985 in the USA&#44; a human patient was implanted for the first time with an implantable cardioverter-defibrillator &#40;ICD&#41;&#46; At that time the device was only indicated for survivors of sudden cardiac death &#40;SCD&#41; in whom malignant ventricular arrhythmias could still be induced in the electrophysiological study while on antiarrhythmic drugs&#46; The implantation procedure was technically complex &#40;the defibrillator lead was epicardial&#41;&#44; ICDs had few of the analytic and decision capabilities available in current devices&#44; and the operative mortality was significant&#46;</p><p id="par0010" class="elsevierStylePara elsevierViewall">The ICD has since become one of the most important therapeutic tools available for reducing mortality in patients with known heart disease and considered&#44; after careful clinical assessment&#44; to be at high risk for SCD&#46;<a class="elsevierStyleCrossRef" href="#bib0125"><span class="elsevierStyleSup">1</span></a> Its efficacy is well documented&#44; both in primary prevention &#40;in patients without known ventricular tachycardia &#91;VT&#93;&#47;ventricular fibrillation &#91;VF&#93; episodes&#41;&#44; and in secondary prevention &#40;after documented VT&#47;VF&#41;&#46;</p><p id="par0015" class="elsevierStylePara elsevierViewall">Cardiac resynchronization therapy &#40;CRT&#41;&#44; which may or may not be associated with an ICD&#44; is indicated for symptomatic patients with congestive heart failure &#40;HF&#41;&#44; severely reduced left ventricular function and left bundle branch block despite optimal medical therapy&#46; In appropriately selected patients &#40;i&#46;e&#46; non-responders to medical therapy&#41;&#44; CRT has demonstrated clear clinical benefits&#44;<a class="elsevierStyleCrossRef" href="#bib0130"><span class="elsevierStyleSup">2</span></a> including significant reductions in mortality&#44; morbidity and hospitalizations &#40;which account for a large proportion of the costs <a class="elsevierStyleCrossRef" href="#bib0125"><span class="elsevierStyleSup">1</span></a> associated with treatment of HF<a class="elsevierStyleCrossRef" href="#bib0135"><span class="elsevierStyleSup">3</span></a>&#41;&#46; CRT has also been shown to halt and even reverse <a class="elsevierStyleCrossRef" href="#bib0130"><span class="elsevierStyleSup">2</span></a> the inexorable worsening of HF&#46; However&#44; the implantation procedure for a CRT device is more complex&#44; given the need for a lead &#40;via a transvenous or epicardial approach&#41; to stimulate the left ventricle&#46;</p><p id="par0020" class="elsevierStylePara elsevierViewall">In Portugal&#44; the first ICD implantation was performed in 1992 at Hospital de Santa Cruz in Lisbon&#46; Making this therapy available to the Portuguese population has not been easy&#44; for various reasons that are beyond the scope of this editorial&#44; although they merit detailed analysis&#46; This difficulty is related not only to questions of cost&#47;benefit&#44; given the significant limitations of funding and human and technical resources in many hospitals&#44; but also &#8211; and most importantly &#8211; to organizational issues&#46; The result is that Portugal has lower device implantation rates than other European Union countries<a class="elsevierStyleCrossRef" href="#bib0140"><span class="elsevierStyleSup">4</span></a> especially for CRT&#44; meaning that Portuguese patients do not have access to treatments that have been demonstrated&#44; beyond any doubt&#44; to confer significant reductions in morbidity and mortality related to severe HF&#46;<a class="elsevierStyleCrossRef" href="#bib0145"><span class="elsevierStyleSup">5</span></a></p><p id="par0025" class="elsevierStylePara elsevierViewall">I welcome the initiative of the Portuguese Institute of Cardiac Rhythm &#40;IPRC&#41; to promote this observational prospective multicenter registry&#44;<a class="elsevierStyleCrossRef" href="#bib0150"><span class="elsevierStyleSup">6</span></a> conducted in 16 Portuguese centers&#44; with the aim of documenting clinical practice in Portugal regarding the use and outcomes of electronic cardiac devices for treating patients with HF and left ventricular ejection fraction &#40;LVEF&#41; &#60;35&#37;&#46;</p><p id="par0030" class="elsevierStylePara elsevierViewall">The primary combined endpoint of the study was all-cause mortality and rehospitalization up to one year after the procedure&#46;</p><p id="par0035" class="elsevierStylePara elsevierViewall">Secondary endpoints were mortality and hospitalization due to HF&#46; The study also aimed to determine patients&#8217; clinical&#44; electrophysiological and echocardiographic characteristics&#44; to identify predictors of response to CRT&#44; to determine in-hospital and outpatient complications and their predictors&#44; and to assess clinical practice in Portugal regarding implantation of ICDs and CRT devices&#46;</p><p id="par0040" class="elsevierStylePara elsevierViewall">The study included patients of both sexes aged 18 years or over with a diagnosis of HF&#44; LVEF &#60;35&#37; and indication for ICD and&#47;or CRT&#46; Five time points for patient assessment were defined&#58; before device implantation&#44; at hospital discharge&#44; and at three&#44; six and 12 &#40;&#177;1&#41; months after implantation&#46; At each assessment&#44; demographic&#44; clinical&#44; laboratory&#44; therapeutic&#44; radiological&#44; echocardiographic&#44; arrhythmic and electrophysiological data were to be provided&#46;</p><p id="par0045" class="elsevierStylePara elsevierViewall">The study also examined the usefulness of the echocardiogram in the selection of patients for CRT&#44; which at the beginning of the study seemed promising&#44; but was not confirmed in later published studies&#46; The registry initially included 515 patients and data on 419 were analyzed&#46; Mean age was 65&#177;12 years and 77&#37; were male&#46; The main etiologies of HF were ischemic &#40;47&#37;&#41; and idiopathic dilated cardiomyopathy &#40;28&#37;&#41;&#46; Of the patients who underwent the initial assessment&#44; half received an ICD and the other half a CRT pacemaker &#40;CRT-P&#41; or CRT defibrillator &#40;CRT-D&#41;&#46; Mean LVEF was 28&#46;7&#177;8&#46;5&#37;&#46; Patients with ICDs had less severe disease than those with a CRT-P or CRT-D&#46; Overall one-year mortality&#44; the study&#39;s primary outcome&#44; was 3&#46;6&#37;&#44; and all-cause rehospitalization was 11&#37;&#46; Cardiovascular mortality was 1&#46;9&#37; and the main cause for rehospitalization at one year was HF &#40;4&#46;5&#37;&#41;&#44; followed by procedure-related complications &#40;2&#46;6&#37;&#41; and arrhythmias &#40;1&#46;4&#37;&#41;&#46; Patients with CRT devices presented higher cardiovascular mortality &#40;3&#46;4&#37; vs&#46; 0&#46;5&#37;&#44; p&#61;0&#46;028&#41; and more were rehospitalized &#40;17&#37; vs&#46; 5&#46;6&#37;&#44; p&#60;0&#46;001&#41; than those with ICDs&#46; There was a trend toward higher overall mortality in patients with ischemic etiology &#40;5&#46;4&#37; vs&#46; 1&#46;9&#37;&#44; p&#61;0&#46;05&#41;&#46; Implantation-related in-hospital complications were uncommon &#40;4&#46;1&#37;&#59; n&#61;17&#41;&#44; occurring mainly in patients with CRT devices&#44; which was related to the greater complexity of the procedure&#46; At one-year follow-up&#44; device-related complications&#44; mainly lead-related&#44; had been recorded in 8&#46;6&#37; of patients&#46; The high rate of appropriate shocks &#40;77&#37;&#41; is noteworthy&#46; Patients undergoing resynchronization presented significant improvements in New York Heart Association &#40;NYHA&#41; functional class &#40;62&#37;&#41;&#44; irrespective of previous QRS duration&#46; A complete echocardiographic assessment was obtained in only 82 patients&#44; in whom the presence of intraventricular dyssynchrony was found to be a predictor of improvement in NYHA functional class &#40;relative risk 5&#46;23&#59; 95&#37; confidence interval&#44; 1&#46;13-24&#46;3&#59; p&#61;0&#46;035&#41;&#46;</p><p id="par0050" class="elsevierStylePara elsevierViewall">This study&#44; which lasted for several years during which there were various changes in the HF guidelines concerning both devices and pharmacological treatment&#44; paints a useful picture of the situation in Portugal with regard to the use of devices and drugs in the treatment of these patients&#46; A significant percentage of them were prescribed the recommended drugs and class I indications were followed for implantation of appropriate devices in this clinical context&#44; but possible deficiencies in referral were identified&#44; due less to funding constraints than to problems with the organization of HF care&#46; The clinical outcomes recorded in this study are better than those obtained in other similar international registries&#46;</p><p id="par0055" class="elsevierStylePara elsevierViewall">This interesting real-life registry demonstrates the usefulness of implantable cardiac devices in the treatment of HF patients&#44; especially non-responders to medical therapy who can benefit from the significant benefit of CRT over optimal medical therapy&#46; It also identifies echocardiography as a tool that should not be neglected and highlights the need for greater cooperation between different specialties within cardiology in the identification and timely referral of patients indicated for device implantation&#46;</p><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0005">Conflicts of interest</span><p id="par0060" class="elsevierStylePara elsevierViewall">The author has no conflicts of interest to declare&#46;</p></span></span>"
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Implantation of resynchronization and/or defibrillation devices in patients with heart failure: Real-life data from the Síncrone study
Dados de vida reais sobre a insuficiência cardíaca antes e após a implantação dos dispositivos de ressincronização e/ou de desfibrilhação – o estudo Síncrone
Victor Sanfins
Serviço de Cardiologia, Centro Hospitalar do Alto Ave, Guimarães, Portugal
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    "textoCompleto" => "<span class="elsevierStyleSections"><p id="par0005" class="elsevierStylePara elsevierViewall">In 1985 in the USA&#44; a human patient was implanted for the first time with an implantable cardioverter-defibrillator &#40;ICD&#41;&#46; At that time the device was only indicated for survivors of sudden cardiac death &#40;SCD&#41; in whom malignant ventricular arrhythmias could still be induced in the electrophysiological study while on antiarrhythmic drugs&#46; The implantation procedure was technically complex &#40;the defibrillator lead was epicardial&#41;&#44; ICDs had few of the analytic and decision capabilities available in current devices&#44; and the operative mortality was significant&#46;</p><p id="par0010" class="elsevierStylePara elsevierViewall">The ICD has since become one of the most important therapeutic tools available for reducing mortality in patients with known heart disease and considered&#44; after careful clinical assessment&#44; to be at high risk for SCD&#46;<a class="elsevierStyleCrossRef" href="#bib0125"><span class="elsevierStyleSup">1</span></a> Its efficacy is well documented&#44; both in primary prevention &#40;in patients without known ventricular tachycardia &#91;VT&#93;&#47;ventricular fibrillation &#91;VF&#93; episodes&#41;&#44; and in secondary prevention &#40;after documented VT&#47;VF&#41;&#46;</p><p id="par0015" class="elsevierStylePara elsevierViewall">Cardiac resynchronization therapy &#40;CRT&#41;&#44; which may or may not be associated with an ICD&#44; is indicated for symptomatic patients with congestive heart failure &#40;HF&#41;&#44; severely reduced left ventricular function and left bundle branch block despite optimal medical therapy&#46; In appropriately selected patients &#40;i&#46;e&#46; non-responders to medical therapy&#41;&#44; CRT has demonstrated clear clinical benefits&#44;<a class="elsevierStyleCrossRef" href="#bib0130"><span class="elsevierStyleSup">2</span></a> including significant reductions in mortality&#44; morbidity and hospitalizations &#40;which account for a large proportion of the costs <a class="elsevierStyleCrossRef" href="#bib0125"><span class="elsevierStyleSup">1</span></a> associated with treatment of HF<a class="elsevierStyleCrossRef" href="#bib0135"><span class="elsevierStyleSup">3</span></a>&#41;&#46; CRT has also been shown to halt and even reverse <a class="elsevierStyleCrossRef" href="#bib0130"><span class="elsevierStyleSup">2</span></a> the inexorable worsening of HF&#46; However&#44; the implantation procedure for a CRT device is more complex&#44; given the need for a lead &#40;via a transvenous or epicardial approach&#41; to stimulate the left ventricle&#46;</p><p id="par0020" class="elsevierStylePara elsevierViewall">In Portugal&#44; the first ICD implantation was performed in 1992 at Hospital de Santa Cruz in Lisbon&#46; Making this therapy available to the Portuguese population has not been easy&#44; for various reasons that are beyond the scope of this editorial&#44; although they merit detailed analysis&#46; This difficulty is related not only to questions of cost&#47;benefit&#44; given the significant limitations of funding and human and technical resources in many hospitals&#44; but also &#8211; and most importantly &#8211; to organizational issues&#46; The result is that Portugal has lower device implantation rates than other European Union countries<a class="elsevierStyleCrossRef" href="#bib0140"><span class="elsevierStyleSup">4</span></a> especially for CRT&#44; meaning that Portuguese patients do not have access to treatments that have been demonstrated&#44; beyond any doubt&#44; to confer significant reductions in morbidity and mortality related to severe HF&#46;<a class="elsevierStyleCrossRef" href="#bib0145"><span class="elsevierStyleSup">5</span></a></p><p id="par0025" class="elsevierStylePara elsevierViewall">I welcome the initiative of the Portuguese Institute of Cardiac Rhythm &#40;IPRC&#41; to promote this observational prospective multicenter registry&#44;<a class="elsevierStyleCrossRef" href="#bib0150"><span class="elsevierStyleSup">6</span></a> conducted in 16 Portuguese centers&#44; with the aim of documenting clinical practice in Portugal regarding the use and outcomes of electronic cardiac devices for treating patients with HF and left ventricular ejection fraction &#40;LVEF&#41; &#60;35&#37;&#46;</p><p id="par0030" class="elsevierStylePara elsevierViewall">The primary combined endpoint of the study was all-cause mortality and rehospitalization up to one year after the procedure&#46;</p><p id="par0035" class="elsevierStylePara elsevierViewall">Secondary endpoints were mortality and hospitalization due to HF&#46; The study also aimed to determine patients&#8217; clinical&#44; electrophysiological and echocardiographic characteristics&#44; to identify predictors of response to CRT&#44; to determine in-hospital and outpatient complications and their predictors&#44; and to assess clinical practice in Portugal regarding implantation of ICDs and CRT devices&#46;</p><p id="par0040" class="elsevierStylePara elsevierViewall">The study included patients of both sexes aged 18 years or over with a diagnosis of HF&#44; LVEF &#60;35&#37; and indication for ICD and&#47;or CRT&#46; Five time points for patient assessment were defined&#58; before device implantation&#44; at hospital discharge&#44; and at three&#44; six and 12 &#40;&#177;1&#41; months after implantation&#46; At each assessment&#44; demographic&#44; clinical&#44; laboratory&#44; therapeutic&#44; radiological&#44; echocardiographic&#44; arrhythmic and electrophysiological data were to be provided&#46;</p><p id="par0045" class="elsevierStylePara elsevierViewall">The study also examined the usefulness of the echocardiogram in the selection of patients for CRT&#44; which at the beginning of the study seemed promising&#44; but was not confirmed in later published studies&#46; The registry initially included 515 patients and data on 419 were analyzed&#46; Mean age was 65&#177;12 years and 77&#37; were male&#46; The main etiologies of HF were ischemic &#40;47&#37;&#41; and idiopathic dilated cardiomyopathy &#40;28&#37;&#41;&#46; Of the patients who underwent the initial assessment&#44; half received an ICD and the other half a CRT pacemaker &#40;CRT-P&#41; or CRT defibrillator &#40;CRT-D&#41;&#46; Mean LVEF was 28&#46;7&#177;8&#46;5&#37;&#46; Patients with ICDs had less severe disease than those with a CRT-P or CRT-D&#46; Overall one-year mortality&#44; the study&#39;s primary outcome&#44; was 3&#46;6&#37;&#44; and all-cause rehospitalization was 11&#37;&#46; Cardiovascular mortality was 1&#46;9&#37; and the main cause for rehospitalization at one year was HF &#40;4&#46;5&#37;&#41;&#44; followed by procedure-related complications &#40;2&#46;6&#37;&#41; and arrhythmias &#40;1&#46;4&#37;&#41;&#46; Patients with CRT devices presented higher cardiovascular mortality &#40;3&#46;4&#37; vs&#46; 0&#46;5&#37;&#44; p&#61;0&#46;028&#41; and more were rehospitalized &#40;17&#37; vs&#46; 5&#46;6&#37;&#44; p&#60;0&#46;001&#41; than those with ICDs&#46; There was a trend toward higher overall mortality in patients with ischemic etiology &#40;5&#46;4&#37; vs&#46; 1&#46;9&#37;&#44; p&#61;0&#46;05&#41;&#46; Implantation-related in-hospital complications were uncommon &#40;4&#46;1&#37;&#59; n&#61;17&#41;&#44; occurring mainly in patients with CRT devices&#44; which was related to the greater complexity of the procedure&#46; At one-year follow-up&#44; device-related complications&#44; mainly lead-related&#44; had been recorded in 8&#46;6&#37; of patients&#46; The high rate of appropriate shocks &#40;77&#37;&#41; is noteworthy&#46; Patients undergoing resynchronization presented significant improvements in New York Heart Association &#40;NYHA&#41; functional class &#40;62&#37;&#41;&#44; irrespective of previous QRS duration&#46; A complete echocardiographic assessment was obtained in only 82 patients&#44; in whom the presence of intraventricular dyssynchrony was found to be a predictor of improvement in NYHA functional class &#40;relative risk 5&#46;23&#59; 95&#37; confidence interval&#44; 1&#46;13-24&#46;3&#59; p&#61;0&#46;035&#41;&#46;</p><p id="par0050" class="elsevierStylePara elsevierViewall">This study&#44; which lasted for several years during which there were various changes in the HF guidelines concerning both devices and pharmacological treatment&#44; paints a useful picture of the situation in Portugal with regard to the use of devices and drugs in the treatment of these patients&#46; A significant percentage of them were prescribed the recommended drugs and class I indications were followed for implantation of appropriate devices in this clinical context&#44; but possible deficiencies in referral were identified&#44; due less to funding constraints than to problems with the organization of HF care&#46; The clinical outcomes recorded in this study are better than those obtained in other similar international registries&#46;</p><p id="par0055" class="elsevierStylePara elsevierViewall">This interesting real-life registry demonstrates the usefulness of implantable cardiac devices in the treatment of HF patients&#44; especially non-responders to medical therapy who can benefit from the significant benefit of CRT over optimal medical therapy&#46; It also identifies echocardiography as a tool that should not be neglected and highlights the need for greater cooperation between different specialties within cardiology in the identification and timely referral of patients indicated for device implantation&#46;</p><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0005">Conflicts of interest</span><p id="par0060" class="elsevierStylePara elsevierViewall">The author has no conflicts of interest to declare&#46;</p></span></span>"
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ISSN: 08702551
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Revista Portuguesa de Cardiologia
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