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临床试验/NCT04045340
NCT04045340已完成不适用

Intraoperative Transesophageal Echocardiography in On-pump Mitral Surgery: A Single Center Prospective Observational Study of Global Longitudinal Strain and Global Longitudinal Strain Rate as Predictors of Unfavorable Outcome

Scientific Institute San Raffaele2 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2019年10月28日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
140
试验地点
2
主要终点
Number of patients with low cardiac output syndrome after mitral valve surgery

研究概览

简要总结

The aim of the present study is to assess the best echocardiographic parameters (GLS, GLS rate and standard echocardiographic parameters) predicting LCOS in on-pump mitral surgery.

详细描述

Low cardiac output syndrome (LCOS) is a common complication in cardiac surgery after weaning from cardiopulmonary bypass (CPB) associated with high morbidity and mortality. Its prompt recognition and management may mitigate the effect of LCOS on the outcome. To date, advanced age, prolonged CPB, urgent surgery and impaired left ventricular function assessed by left ventricular ejection fraction (LVEF) are commonly considered strong predictors of postoperative LCOS. Nevertheless, LVEF has several limitations including image quality, operator experience, limited reproducibility, inter- and intra-observer discrepancy and load/volume dependency. Global Longitudinal Strain (GLS), with automated speckle-tracking echocardiography (STE) may overcome several of the LVEF limitations. In fact, while the LVEF detects changes in left ventricular chamber volume, GLS reflects myocardial longitudinal deformation due to contraction. The rate of myocardial deformation over time (expressed as 1/s) is called GLS Rate. Global Longitudinal Strain, mostly evaluated from transthoracic echocardiography (TTE), has shown lower inter- and intra-observer variability, a better reproducibility and prognostic value compared to LVEF in a generic cardiac population. In addition the results of the GLS with TTE (GLS-TTE) may not be shifted in cardiac surgery due to the effect of the general anesthesia (GA) and positive pressure ventilation. Thus, these factors should be considered when the global longitudinal strain, evaluated from transesophageal echocardiography (GLS-TEE) is used as predictor of early outcome. Amabili et al. have shown that GLS-TEE is better than LVEF in predicting LCOS in a general cardiac surgery population. Similarly Sonny et al. in patients undergoing aortic valve surgery for stenosis have reported that a GLS-TEE and GLS-TEE Rate are superior to standard echocardiographic parameters in predicting a complicated course. To the best of our knowledge, there are no studies investigating the role of intraoperative evaluation of GLS-TEE and GLS-TEE Rate as predictors of LCOS in mitral valve surgery. In this setting LVEF is not a reliable marker of cardiac function due to a systematic overestimation of the ejection fraction. Moreover these patients are at high risk of postoperative cardiac dysfunction and LCOS owing to the afterload mismatch after mitral surgery. For the reasons mentioned above, more effective predictors are advocated. In the present study we try to fill the gap. Thus, aim of present study is to assess the role of GLS-TEE, GLS-TEE Rate and standard echocardiographic parameters in predicting LCOS in on-pump mitral surgery. In doing so, the best cut-off for each echocardiographic parameter will be provided. Finally to detect the effect of the GA, the echocardiographic parameters calculated after the induction of GA will be compared with those collected preoperatively.

A telephonic follow-up will be performed at 30 days and 12-months investigating mortality and rehospitalization due to heart failure.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All patients undergoing elective or urgent open mitral valve repair or mitral valve replacement over 18 years
  • Ability to sign informed consent
  • Availability of pre-CBP and after-CPB intraoperative transesophageal echocardiography which include a 4-chambers, 2-chambers and a long axis view at a minimum frame rate of 50 Hz
  • Good quality echocardiographic images with a optimal endocardial definition
  • Good quality ECG tracing

排除标准

  • All patients undergoing emergent open mitral valve repair or mitral valve replacement
  • Unavailability of pre-CBP and after-CPB intraoperative transesophageal echocardiography which include a 4-chambers, 2-chambers and a long axis view at a minimum frame rate of 50 Hz
  • Poor quality echocardiographic images
  • ECG artefacts

结局指标

主要结局

Number of patients with low cardiac output syndrome after mitral valve surgery

时间窗: 30 days

Global longitudinal strain threshold associated with LCOS after mitral valve surgery

时间窗: Intraoperative 6 hours

Global longitudinal strain of myocardium in mitral valve surgery

时间窗: Intraoperative 6 hours

Offline processing of GLS, GLS Rate

次要结局

  • Post-operative rate of hepatic dysfunction(30 days)
  • Length of hospital stay(30 days)
  • 30-day or in hospital mortality(30 days)
  • Effect of general anesthesia on systole and diastole(Intraoperative 6 hours)
  • Length of intensive care unit stay(30 days)
  • Post-operative rate of acute kidney injury(30 days)
  • All-cause mortality during the follow-up(30 days and 1years)
  • Duration of post-operative mechanical ventilation(30 days)
  • Readmission rate in intensive care(30 days)

研究者

发起方
Scientific Institute San Raffaele
申办方类型
Other
责任方
Principal Investigator
主要研究者

Fabrizio Monaco

Head of Cardiac and Vascular Anestesia

Scientific Institute San Raffaele

研究点 (2)

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