Currently submitted to: Journal of Medical Internet Research
Date Submitted: Jul 7, 2020
Open Peer Review Period: Jul 7, 2020 - Sep 1, 2020
(currently open for review)
Development and External Validation of Diagnostic Model for Periprocedural Bradycardia during Primary Percutaneous Coronary Intervention: Algorithm Development and Validation
Periprocedural bradycardia weaks the benefit of primary percutaneous coronary intervention (PPCI) and has deleterious effects on organ perfusion of patients with acute ST elevation myocardial infarction (STEMI).
The objective of our study was to develop and externally validate a diagnostic model of periprocedural bradycardia. .
Design: Multivariate logistic regression of a cohort of acute STEMI patients. Setting: Emergency department ward of a university hospital. Participants: Diagnostic model development: Totally 1820 acute STEMI patients who were consecutively treated with PPCI from November 2007 to December 2015 in Beijing Anzhen Hospital, Capital Medical University. External validation: Totally 716 acute STEMI patients who were treated with PPCI from January 2016 to June 2018 in Beijing Anzhen Hospital, Capital Medical University. Outcomes: Periprocedural bradycardia during PPCI. Periprocedural bradycardia was defined as preoperative heart rate ≥ 50 times / min, intraoperative heart rate <50 times / min persistent or transient. We used logistic regression analysis to analyze the risk factors of periprocedural bradycardia in the development data set. We developed a diagnostic model of periprocedural bradycardia and constructed a nomogram.We assessed the predictive performance of the diagnostic model in the validation data sets by examining measures of discrimination, calibration, and decision curve analysis (DCA).
Periprocedural bradycardia occurred in 332 out of 1,820 participants (18.2%) in the development dataset. The strongest predictors of periprocedural bradycardia were intra-procedural hypotension, the culprit vessel was not left anterior descending (LAD), using thrombus aspiration devices during procedure, sex, history of coronary artery disease, total occlusion of culprit vessel, and no-reflow. We developed a diagnostic model of periprocedural bradycardia.The area under the receiver operating characteristic(ROC) curve(AUC) was was.8384 ±.0122, 95% confidence interval(CI)=.81460~.86225in the development set. We constructed a nomogram based on predictors of periprocedural bradycardia. Periprocedural bradycardia occurred in 102 out of 716 participants (14.2%)in the validation dataset. The AUC was was .8437 ±.0203, 95% CI= .80390 ~ .88357. Discrimination, calibration, and DCA were satisfactory. Date of approved by ethic committee:16 May 2019. Date of data collection start: 1 June 2019. Numbers recruited as of submission of the manuscript:2,536.
We developed and externally validated a diagnostic model of periprocedural bradycardia during PPCI. Clinical Trial: We registered this study with WHO International Clinical Trials Registry Platform（ICTRP）. Registration number: ChiCTR1900023214. Registered Date :16 May 2019. http://www.chictr.org.cn/edit.aspx?pid=39087&htm=4.
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