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    "textoCompleto" => "<span class="elsevierStyleSections"><p id="par0005" class="elsevierStylePara elsevierViewall"><elsevierMultimedia ident="tb0005"></elsevierMultimedia></p><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0005">Abstract</span><p id="par0015" class="elsevierStylePara elsevierViewall"><span class="elsevierStyleBold">Importance&#58;</span> Patient selection for transcatheter aortic valve replacement &#40;TAVR&#41; should include assessment of the risks of TAVR compared with surgical aortic valve replacement &#40;SAVR&#41;&#46; Existing SAVR risk models accurately predict the risks for the population undergoing SAVR&#44; but comparable models to predict risk for patients undergoing TAVR are currently not available and should be derived from a population that underwent TAVR&#46;</p><p id="par0020" class="elsevierStylePara elsevierViewall"><span class="elsevierStyleBold">Objective&#58;</span> To use a national population of patients undergoing TAVR to develop a statistical model that will predict in&#8208;hospital mortality after TAVR&#46;</p><p id="par0025" class="elsevierStylePara elsevierViewall"><span class="elsevierStyleBold">Design&#44; Setting&#44; and Participants&#58;</span> Patient data were obtained from the Society of Thoracic Surgeons&#47;American College of Cardiology Transcatheter Valve Therapy &#40;STS&#47;ACC TVT&#41; Registry&#46; The model was developed from 13718 consecutive US patients undergoing TAVR in centers participating in the STS&#47;ACC TVT Registry from November 1&#44; 2011&#44; to February 28&#44; 2014&#46; Validation was conducted using 6868 records of consecutive patients undergoing TAVR from March 1 to October 8&#44; 2014&#46; Covariates were selected through a process of expert opinion and statistical analysis&#46; The association between in&#8208;hospital mortality and baseline covariates was estimated using logistic regression&#46; The final set of predictors was selected via stepwise variable selection&#46; Data were collected and analyzed from November 1&#44; 2011&#44; to February 28&#44; 2014&#46;</p><p id="par0030" class="elsevierStylePara elsevierViewall"><span class="elsevierStyleBold">Main Outcomes and Measures&#58;</span> In&#8208;hospital TAVR mortality&#46;</p><p id="par0035" class="elsevierStylePara elsevierViewall"><span class="elsevierStyleBold">Results&#58;</span> The development sample included 13718 patient records from 265 participant sites &#40;of 13 672 with data available&#44; 6680 men &#91;48&#46;9&#37;&#93;&#59; 6992 women &#91;51&#46;1&#37;&#93;&#59; mean &#91;SD&#93; age&#44; 82&#46;1 &#91;8&#46;3&#93; years&#41;&#46; The final validation cohort included 6868 patients from 314 participating centers &#40;3554 men &#91;51&#46;7&#37;&#93;&#59; 3314 women &#91;48&#46;3&#37;&#93;&#59; mean &#91;SD&#93; age&#44; 81&#46;6 &#91;8&#46;8&#93; years&#41;&#46; In&#8208;hospital mortality occurred in 730 patients &#40;5&#46;3&#37;&#41;&#46; The <span class="elsevierStyleSmallCaps">C</span> statistic for discrimination was 0&#46;67 &#40;95&#37; CI&#44; 0&#46;65&#8208;0&#46;69&#41; in the development group and 0&#46;66 &#40;95&#37; CI&#44; 0&#46;62&#8208;0&#46;69&#41; in the validation group&#46; The final model covariates &#40;reported as odds ratios&#59; 95&#37; CIs&#41; were age &#40;1&#46;13&#59; 1&#46;06&#8208;1&#46;20&#41;&#44; glomerular filtration rate per 5&#8208;U increments &#40;0&#46;93&#59; 0&#46;91&#8208;0&#46;95&#41;&#44; hemodialysis &#40;3&#46;25&#59; 2&#46;42&#8208;4&#46;37&#41;&#44; New York Heart Association functional class <span class="elsevierStyleSmallCaps">IV</span> &#40;1&#46;25&#59; 1&#46;03&#8208;1&#46;52&#41;&#44; severe chronic lung disease &#40;1&#46;67&#59; 1&#46;35&#8208;2&#46;05&#41;&#44; nonfemoral access site &#40;1&#46;96&#59; 1&#46;65&#8208; 2&#46;33&#41;&#44; and procedural acuity categories 2 &#40;1&#46;57&#59; 1&#46;20&#8208;2&#46;05&#41;&#44; 3 &#40;2&#46;70&#59; 2&#46;05&#8208;3&#46;55&#41;&#44; and 4 &#40;3&#46;34&#59; 1&#46;59&#8208;7&#46;02&#41;&#46; Calibration analysis demonstrated no significant difference between the model &#40;predicted vs observed&#41; calibration line &#40;&#8722;0&#46;18 and 0&#46;97 for intercept and slope&#44; respectively&#41; compared with the ideal calibration line&#46;</p><p id="par0040" class="elsevierStylePara elsevierViewall"><span class="elsevierStyleBold">Conclusions and Relevance&#58;</span> Data from the STS&#47;ACC TVT Registry have been used to develop a predictive model of in&#8208;hospital mortality for patients undergoing TAVR&#46; Validation based on a population of patient records not used in model development demonstrates discrimination and calibration indices that are more favorable than other models used in populations with TAVR&#46; This model should be a valuable adjunct for patient counseling&#44; local quality improvement&#44; and national monitoring for appropriateness of selection of patients for TAVR&#46;</p></span><span id="sec0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0010">Coment&#225;rio</span><p id="par0045" class="elsevierStylePara elsevierViewall">Na edi&#231;&#227;o de abril de 2016 do <span class="elsevierStyleItalic">JAMA Cardiology</span>&#44; Edwards e associados<a class="elsevierStyleCrossRef" href="#bib0020"><span class="elsevierStyleSup">1</span></a> publicam um estudo que teve como objetivo construir um modelo de predi&#231;&#227;o de risco para mortalidade intra&#8208;hospitalar na popula&#231;&#227;o norte&#8208;americana submetida a implanta&#231;&#227;o transcateter da v&#225;lvula a&#243;rtica &#40;TAVI&#41;&#46;</p><p id="par0050" class="elsevierStylePara elsevierViewall">Os dados dos doentes inclu&#237;dos no estudo provieram do registo nacional norte&#8208;americano &#171;<span class="elsevierStyleItalic">The STS&#8208;ACC Transcatheter Valve Therapy National Registry</span>&#187;&#46; O modelo foi desenvolvido com dados de 13 718 doentes submetidos consecutivamente a TAVI entre novembro de 2011 e fevereiro de 2014&#59; a valida&#231;&#227;o do modelo foi realizada em 6868 doentes tratados entre mar&#231;o e outubro de 2014&#46; De entre um conjunto de 39 vari&#225;veis pr&#233;&#8208;operat&#243;rias existentes na base de dados&#44; 14 foram selecionadas para an&#225;lise <span class="elsevierStyleItalic">via expert consensus</span>&#44; e&#44; finalmente&#44; nove destas vari&#225;veis foram retidas no modelo final utilizando metodologia estat&#237;stica anal&#237;tica&#46; O poder discriminat&#243;rio do modelo &#233; ligeiro &#40;a &#225;rea abaixo da curva ROC foi de 0&#44;67 no grupo de desenvolvimento e de 0&#44;66 no grupo de valida&#231;&#227;o&#41;&#46; Estes resultados atestam a limitada capacidade discriminativa neste grupo de doentes&#46; Mesmo os &#171;melhores&#187; modelos de risco dispon&#237;veis explicam apenas uma pequena propor&#231;&#227;o da variabilidade dos resultados&#46; &#201; por esta raz&#227;o que as mais recentes recomenda&#231;&#245;es enfatizam que a avalia&#231;&#227;o do risco deve apoiar&#8208;se essencialmente na avalia&#231;&#227;o cl&#237;nica<a class="elsevierStyleCrossRefs" href="#bib0025"><span class="elsevierStyleSup">2&#44;3</span></a>&#46;</p><p id="par0055" class="elsevierStylePara elsevierViewall">Um conjunto de limita&#231;&#245;es ao estudo merece reflex&#227;o&#46; Algumas s&#227;o elencadas pelos autores&#44; nomeadamente&#58; dados em falta&#44; um processo de auditoria incompleto&#44; aus&#234;ncia de indicadores de fragilidade e de qualidade de vida e o facto de terem restringido a um per&#237;odo temporal muito curto a an&#225;lise da mortalidade&#46; Penso que&#44; a esta lista deveriam ter sido adicionados outros aspetos tais como&#58; aus&#234;ncia de informa&#231;&#227;o relativamente a complica&#231;&#245;es <span class="elsevierStyleItalic">major</span>&#44; quer card&#237;aca quer n&#227;o card&#237;aca&#44; bem como informa&#231;&#227;o adicional clarificadora relativamente ao modo como as vari&#225;veis foram selecionadas para an&#225;lise <span class="elsevierStyleItalic">via expert consensus</span>&#46;</p></span><span id="sec0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0015">Conflito de interesses</span><p id="par0060" class="elsevierStylePara elsevierViewall">O autor declara n&#227;o haver conflito de interesses&#46;</p></span></span>"
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Vol. 35. Issue 7 - 8.
Pages 457-458 (July - August 2016)
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Comentário a «Desenvolvimento e validação de um modelo de predição de risco para mortalidade intra‐hospitalar em doentes submetidos a implantação transcateter da válvula aórtica»
Comment on “Development and Validation of a Risk Prediction Model for In‐Hospital Mortality After Transcatheter Aortic Valve Replacement”
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Pedro E. Antunes
Membro do Corpo Redatorial da Revista Portuguesa de Cardiologia
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Fred H. Edwards, MD; David J. Cohen, MD; Sean M. O’Brien, PhD; Eric D. Peterson, MD, MPH; Michael J. Mack, MD; David M. Shahian, MD; Frederick L. Grover, MD; E. Murat Tuzcu, MD; Vinod H. Thourani, MD; John Carroll, MD; J. Matthew Brennan, MD, MPH; Ralph G. Brindis, MD, MPH; John Rumsfeld, MD, PhD; David R. Holmes Jr, MD; for the Steering Committee of the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry. JAMA Cardiol. 2016;1(1):46‐52. doi:10.1001/jamacardio.2015.0326

Abstract

Importance: Patient selection for transcatheter aortic valve replacement (TAVR) should include assessment of the risks of TAVR compared with surgical aortic valve replacement (SAVR). Existing SAVR risk models accurately predict the risks for the population undergoing SAVR, but comparable models to predict risk for patients undergoing TAVR are currently not available and should be derived from a population that underwent TAVR.

Objective: To use a national population of patients undergoing TAVR to develop a statistical model that will predict in‐hospital mortality after TAVR.

Design, Setting, and Participants: Patient data were obtained from the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy (STS/ACC TVT) Registry. The model was developed from 13718 consecutive US patients undergoing TAVR in centers participating in the STS/ACC TVT Registry from November 1, 2011, to February 28, 2014. Validation was conducted using 6868 records of consecutive patients undergoing TAVR from March 1 to October 8, 2014. Covariates were selected through a process of expert opinion and statistical analysis. The association between in‐hospital mortality and baseline covariates was estimated using logistic regression. The final set of predictors was selected via stepwise variable selection. Data were collected and analyzed from November 1, 2011, to February 28, 2014.

Main Outcomes and Measures: In‐hospital TAVR mortality.

Results: The development sample included 13718 patient records from 265 participant sites (of 13 672 with data available, 6680 men [48.9%]; 6992 women [51.1%]; mean [SD] age, 82.1 [8.3] years). The final validation cohort included 6868 patients from 314 participating centers (3554 men [51.7%]; 3314 women [48.3%]; mean [SD] age, 81.6 [8.8] years). In‐hospital mortality occurred in 730 patients (5.3%). The C statistic for discrimination was 0.67 (95% CI, 0.65‐0.69) in the development group and 0.66 (95% CI, 0.62‐0.69) in the validation group. The final model covariates (reported as odds ratios; 95% CIs) were age (1.13; 1.06‐1.20), glomerular filtration rate per 5‐U increments (0.93; 0.91‐0.95), hemodialysis (3.25; 2.42‐4.37), New York Heart Association functional class IV (1.25; 1.03‐1.52), severe chronic lung disease (1.67; 1.35‐2.05), nonfemoral access site (1.96; 1.65‐ 2.33), and procedural acuity categories 2 (1.57; 1.20‐2.05), 3 (2.70; 2.05‐3.55), and 4 (3.34; 1.59‐7.02). Calibration analysis demonstrated no significant difference between the model (predicted vs observed) calibration line (−0.18 and 0.97 for intercept and slope, respectively) compared with the ideal calibration line.

Conclusions and Relevance: Data from the STS/ACC TVT Registry have been used to develop a predictive model of in‐hospital mortality for patients undergoing TAVR. Validation based on a population of patient records not used in model development demonstrates discrimination and calibration indices that are more favorable than other models used in populations with TAVR. This model should be a valuable adjunct for patient counseling, local quality improvement, and national monitoring for appropriateness of selection of patients for TAVR.

Comentário

Na edição de abril de 2016 do JAMA Cardiology, Edwards e associados1 publicam um estudo que teve como objetivo construir um modelo de predição de risco para mortalidade intra‐hospitalar na população norte‐americana submetida a implantação transcateter da válvula aórtica (TAVI).

Os dados dos doentes incluídos no estudo provieram do registo nacional norte‐americano «The STS‐ACC Transcatheter Valve Therapy National Registry». O modelo foi desenvolvido com dados de 13 718 doentes submetidos consecutivamente a TAVI entre novembro de 2011 e fevereiro de 2014; a validação do modelo foi realizada em 6868 doentes tratados entre março e outubro de 2014. De entre um conjunto de 39 variáveis pré‐operatórias existentes na base de dados, 14 foram selecionadas para análise via expert consensus, e, finalmente, nove destas variáveis foram retidas no modelo final utilizando metodologia estatística analítica. O poder discriminatório do modelo é ligeiro (a área abaixo da curva ROC foi de 0,67 no grupo de desenvolvimento e de 0,66 no grupo de validação). Estes resultados atestam a limitada capacidade discriminativa neste grupo de doentes. Mesmo os «melhores» modelos de risco disponíveis explicam apenas uma pequena proporção da variabilidade dos resultados. É por esta razão que as mais recentes recomendações enfatizam que a avaliação do risco deve apoiar‐se essencialmente na avaliação clínica2,3.

Um conjunto de limitações ao estudo merece reflexão. Algumas são elencadas pelos autores, nomeadamente: dados em falta, um processo de auditoria incompleto, ausência de indicadores de fragilidade e de qualidade de vida e o facto de terem restringido a um período temporal muito curto a análise da mortalidade. Penso que, a esta lista deveriam ter sido adicionados outros aspetos tais como: ausência de informação relativamente a complicações major, quer cardíaca quer não cardíaca, bem como informação adicional clarificadora relativamente ao modo como as variáveis foram selecionadas para análise via expert consensus.

Conflito de interesses

O autor declara não haver conflito de interesses.

Bibliografia
[1]
F.H. Edwards, D.J. Cohen, S.M. O’Brien, et al.
Steering Committee of the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry. Development and validation of a risk prediction model for in‐hospital mortality after transcatheter aortic valve replacement.
JAMA Cardiol., 1 (2016), pp. 46-50
[2]
A. Vahanian, O. Alfieri, F. Andreotti, et al.
Guidelines on the management of valvular heart disease (version 2012): The Joint Task Force on the Management of Valvular Heart Disease of the European Society of Cardiology (ESC) and the European Association for Cardio‐Thoracic Surgery (EACTS).
Eur Heart J., 33 (2012), pp. 2451-2496
[3]
R.A. Nishimura, C.M. Otto, R.O. Bonow, et al.
2014 AHA/ACC Guideline for the Management of Patients With Valvular Heart Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines.
Circulation., 129 (2014 10), pp. e521-e643
Copyright © 2016. Sociedade Portuguesa de Cardiologia
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