英国爱丁堡大学Nicholas L Mills团队对急性心力衰竭诊断决策支持工具进行了开发和验证。这一研究成果于2022年6月13日发表在《英国医学杂志》上。

为了评估N端B型脑钠肽前体（NT-proBNP）阈值对急性心力衰竭的诊断性能，并开发和验证一种将NT-proBNP水平与临床特征相结合的决策支持工具，研究组对13个国家进行的14项研究，包括随机对照试验和前瞻性观察研究中个体患者层面的数据，进行荟萃分析和建模研究。

研究组收集10369例疑似急性心力衰竭患者的个体患者水平数据并进行荟萃分析，以评估NT-proBNP阈值。他们开发并验证了一种决策支持工具（心力衰竭诊断和评估协作[CoDE-HF]），该工具将NT-proBNP与临床变量相结合，以报告单个患者急性心力衰竭的概率。主要结局指标为确诊急性心力衰竭。

总体来说，43.9%（4549/10369） 的患者被判定为急性心力衰竭，其中有心力衰竭史的患者中为73.3%（2286/3119），无心力衰竭史的患者中为29.0%（1802/6208）。指南推荐的300 pg/mL排除阈值的阴性预测值为94.6%；尽管在阈值中使用了年龄特异性规则，但在年龄<50岁、50-75岁和>75岁的患者中，阳性预测值分别为61.0%、73.5%和80.2%。大多数亚组的表现各不相同，尤其是肥胖、肾功能损害或既往心力衰竭患者。

CoDE-HF校准良好，对既往有心衰和无心衰的患者（受试者-操作员曲线下面积分别为0.846和0.925，Brier得分分别为0.130和0.099）具有极好的辨别力。在既往无心衰的患者中，所有亚组的诊断表现都是一致的，40.3%（2502/6208）被确定为急性心衰概率极低（阴性预测值为98.6%），28.0%（1737/6208）被确定为急性心衰概率较高（阳性预测值为75.0%）。

研究结果表明，在这项对NT-proBNP诊断性能的国际合作评估中，指南推荐的急性心力衰竭诊断阈值在重要患者亚组中差异很大。CoDE-HF决策支持工具将NT-proBNP作为连续测量和其他临床变量结合起来，提供了更一致、准确和个性化的方法。

附：英文原文

Title: Development and validation of a decision support tool for the diagnosis of acute heart failure: systematic review, meta-analysis, and modelling study

Author: Kuan Ken Lee, Dimitrios Doudesis, Mohamed Anwar, Federica Astengo, Camille Chenevier-Gobeaux, Yann-Erick Claessens, Desiree Wussler, Nikola Kozhuharov, Ivo Strebel, Zaid Sabti, Christopher deFilippi, Stephen Seliger, Gordon Moe, Carlos Fernando, Antoni Bayes-Genis, Roland R J van Kimmenade, Yigal Pinto, Hanna K Gaggin, Jan C Wiemer, Martin Mckel, Joost H W Rutten, Anton H van den Meiracker, Luna Gargani, Nicola R Pugliese, Christopher Pemberton, Irwani Ibrahim, Alfons Gegenhuber, Thomas Mueller, Michael Neumaier, Michael Behnes, Ibrahim Akin, Michele Bombelli, Guido Grassi, Peiman Nazerian, Giovanni Albano, Philipp Bahrmann, David E Newby, Alan G Japp, Athanasios Tsanas, Anoop S V Shah, A Mark Richards, John J V McMurray, Christian Mueller, James L Januzzi, Nicholas L Mills

Issue&Volume: 2022/06/13

Abstract:

Objectives To evaluate the diagnostic performance of N-terminal pro-B-type natriuretic peptide (NT-proBNP) thresholds for acute heart failure and to develop and validate a decision support tool that combines NT-proBNP concentrations with clinical characteristics.

Design Individual patient level data meta-analysis and modelling study.

Setting Fourteen studies from 13 countries, including randomised controlled trials and prospective observational studies.

Participants Individual patient level data for 10369 patients with suspected acute heart failure were pooled for the meta-analysis to evaluate NT-proBNP thresholds. A decision support tool (Collaboration for the Diagnosis and Evaluation of Heart Failure (CoDE-HF)) that combines NT-proBNP with clinical variables to report the probability of acute heart failure for an individual patient was developed and validated.

Main outcome measure Adjudicated diagnosis of acute heart failure.

Results Overall, 43.9% (4549/10369) of patients had an adjudicated diagnosis of acute heart failure (73.3% (2286/3119) and 29.0% (1802/6208) in those with and without previous heart failure, respectively). The negative predictive value of the guideline recommended rule-out threshold of 300 pg/mL was 94.6% (95% confidence interval 91.9% to 96.4%); despite use of age specific rule-in thresholds, the positive predictive value varied at 61.0% (55.3% to 66.4%), 73.5% (62.3% to 82.3%), and 80.2% (70.9% to 87.1%), in patients aged <50 years, 50-75 years, and >75 years, respectively. Performance varied in most subgroups, particularly patients with obesity, renal impairment, or previous heart failure. CoDE-HF was well calibrated, with excellent discrimination in patients with and without previous heart failure (area under the receiver operator curve 0.846 (0.830 to 0.862) and 0.925 (0.919 to 0.932) and Brier scores of 0.130 and 0.099, respectively). In patients without previous heart failure, the diagnostic performance was consistent across all subgroups, with 40.3% (2502/6208) identified at low probability (negative predictive value of 98.6%, 97.8% to 99.1%) and 28.0% (1737/6208) at high probability (positive predictive value of 75.0%, 65.7% to 82.5%) of having acute heart failure.

Conclusions In an international, collaborative evaluation of the diagnostic performance of NT-proBNP, guideline recommended thresholds to diagnose acute heart failure varied substantially in important patient subgroups. The CoDE-HF decision support tool incorporating NT-proBNP as a continuous measure and other clinical variables provides a more consistent, accurate, and individualised approach.

DOI: 10.1136/bmj-2021-068424

Source: https://www.bmj.com/content/377/bmj-2021-068424