Real-time Pressure Volume Loop Monitoring as a Guide for Enhanced Understanding of Changes in Elemental Cardiovascular Physiology During Therapeutic Strategies Aiming for Hemodynamic Optimization. Cohort II: Structural Heart Interventions (PLUTO-II)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 157
- 试验地点
- 1
- 主要终点
- Cardiac mechanoenergetics
研究概览
简要总结
The aim of PLUTO-II is to use biventricular pressure-volume (PV) loop measurements to improve the understanding of direct changes in cardiac and hemodynamic physiology induced by transcatheter aortic valve implantation (TAVI) or tricuspid edge-to-edge repair (TEER). These procedures evoke immediate changes in cardiac mechanoenergetics, ventricular-vascular interaction as well as ventricular (in)dependency. Within the context of PLUTO-II, patients will undergo biventricular PV-loop measurements before and after TAVI or TEER. In future, the application of perprocedural PV loop monitoring may tailor the daily individual decision making process during structural interventions in the catheterization laboratory.
详细描述
Pressure-Volume (PV) loop monitoring is a tool allowing direct visualization of individual cardiac and hemodynamic physiology, including parameters reflecting cardiac mechanoenergetics (a derivative of the myocardial metabolic demand) as well as the ventricular-arterial coupling. The concepts of changing biventricular cardiac and hemodynamic physiology induced by structural heart interventions, including Transcatheter Aortic Valve Implantation (TAVI), Transcatheter Edge-to-Edge Mitral Repair (mitral TEER) and Transcatheter Edge-to-Edge Tricuspid Repair (tricuspid TEER) are largely based on hypotheses, computer simulations and non-invasive (echocardiographic) estimations. PVL monitoring has the potential to identify unique characteristics of TAVI, mitral TEER and tricuspid TEER from the perspective of changing baseline cardiovascular physiology, including (a change in) interference between both ventricles (i.e. the ventricular crosstalk). Perprocedural (biventricular) PV loop monitoring can be of direct clinical relevance by appreciating the ventricular tolerance of increased cardiac afterload induced by the particular intervention in individual patients. In future, real-time PV loop analysis can be adjunctive to the individual decision-making process during routine structural interventions.
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
- 否
入选标准
- •Adult patients undergoing elective Transcatheter Aortic Valve Implantation (TAVI) or Transcatheter Edge-to-Edge repair (TEER).
排除标准
- •Confirmed or suspected (concomitant) congenital heart disease.
- •Mechanical circulatory support (including Impella, PulseCath, Intra-Aortic Balloon Counterpulsation or Extracorporeal Membrane Oxygenation) was used during the procedure aiming to improve native cardiac output.
- •No (written) informed consent was obtained.
结局指标
主要结局
Cardiac mechanoenergetics
时间窗: Periprocedural time window
The change in cardiac mechanoenergetics (stroke work, potential energy and pressure-volume area in mmHg/mL) induced by the particular procedure
次要结局
- Mortality(30-day follow-up)
- Hospital stay(30-day follow-up)
- Preload recruitable stroke work (mmHg/mL)(Periprocedural change (directly before vs. after the procedure))
- End-systolic elastance (Ees) and arterial elastance (Ea) (mmHg/mL)(Periprocedural change (directly before vs. after the procedure))
- End-systolic and end-diastolic volume (mL)(Periprocedural change (directly before vs. after the procedure))
- V0, V15, V30 and V100 mmHg (mL)(Periprocedural change (directly before vs. after the procedure))
- Beta (ventricular stiffness constant, unitless)(Periprocedural change (directly before vs. after the procedure))
- Stroke volume (mL)(Periprocedural change (directly before vs. after the procedure))
- Starling Contractile Index (mmHg/mL)(Periprocedural change (directly before vs. after the procedure))
- Postprocedural morbidity (%)(30-day follow-up)
- Tau (ms)(Periprocedural change (directly before vs. after the procedure))
- Intraventricular dyssynchrony (%)(Periprocedural change (directly before vs. after the procedure))
- End-systolic and end-diastolic pressure (mmHg)(Periprocedural change (directly before vs. after the procedure))
- SW/PVA ratio (based on the primary outcome)(Periprocedural change (directly before vs. after the procedure))
- dP/dt min and dP/dt max (mmHg/sec)(Periprocedural change (directly before vs. after the procedure))
研究者
Nicolas van Mieghem
prof. dr. N.M. Van Mieghem
Erasmus Medical Center