Pilot Study: Noninvasive Cardiovascular Diagnosis of Patients With Fully Magnetically Levitated Blood Pumps
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Incidence of suction events and suction burden (percentage number of suction operation in relation to normal operation) evaluated using routinely available HeartMate 3 log files and high-resolution CDAS data
研究概览
简要总结
Left Ventricular Assist Device (LVAD) therapy has become a well-established treatment option for endstage heart-failure either as a bridge to transplant (BTT) or destination therapy (DT). Monitoring of the pump and with this the cardiac status with the HeartMate 3 (HM3) is currently very limited to infrequent log-files with one data entry every 15 minutes and only limited amount of entries. Due to the low resolution data, the standard HM3 monitoring is not feasible for the evaluation of suction events or in depth analysis of the interaction between LVAD and the remaining native heart function. Aim of this study is to develop noninvasive diagnostics of the cardiac remaining respectively recovering function derived from HeartMate 3 pump data only and compare with standard clinical diagnostic procedures. These procedures include cardiac ultrasound and ECG. After this pilot study, the newly developed methods would allow frequent, simple and automatic monitoring of patients implanted with the HeartMate 3 device. Such continuous assessment of cardiac function would massively help therapy optimization of cardiac protection and, if possible, cardiac recovery.
详细描述
- Background
Left Ventricular Assist Device (LVAD) therapy has become a well-established treatment option for endstage heart-failure either as a bridge to transplant (BTT) or destination therapy (DT). Currently, continuous flow LVADs are operated at a constant rotational speed, which results in a fixed relation between the difference between pump inlet and outlet pressure (=head pressure) and pump flowrate. This results in a cardiac support, which is not very adaptable to physiologic demand or preload changes due to reduced venous return and subsequent preload reduction e.g. due to hypovolemia. Nonetheless it could be shown, that optimal setting of LVAD support is essential to optimize patient outcomes.
Proper measurement for cardiovascular function under LVAD support is therefore of key importance, especially as unwanted pumping conditions such as "overpumping", causing a collapse of structures of the left ventricle (LV), also referred to as suction. This could lead to suction induced arrhythmia (or tachycardia) as well as impairments to the right ventricle (e.g. tricuspid valve insufficiency) due to a ventricular septum shift.
Ultrasound and cardiac catheterization are the standard clinical methods for the evaluation of morphological and functional properties of the heart, and also eventually changing properties of the aortic valve. Further diagnostics include conventional ECG analysis but also heart rate variability to obtain information of the neurohumoral status. Exercise stress tests and recently developed activity diagnostics give further important information about overall recovery and quality of life.
All these methods however require time-consuming procedures, being unacceptably cumbersome for frequent monitoring. On the other hand, a frequent and effective noninvasive evaluation of the cardiac status provided by the rotary blood pump (RBP) itself would have a remarkable impact on LVAD patients and their therapy, especially for the evaluation of their overall and cardiac recovery.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients with the HeartMate 3 system implanted at the Medical University of Vienna, which are able and willing to understand and sign the informed consent form, and which do not meet any
排除标准
- •will be included.
- •Exclusion Criteria:
- •Age: <18 or >75 years
- •Inability to provide informed consent
- •Patients with known intraventricular or aortic root thrombus formation or known pathology of the coagulatory system. Although an intraventricular thrombus formation is usually removed intraoperatively during the LVAD implantation procedure, the rationale for this exclusion criterion is to avoid suction of such thrombus material during possible speed changes (± 20% from the initial pump speed). Consequently, the exclusion of patients with known pathology of the coagulation system, who thus have a higher risk of developing any kind of thrombus formation, is another safety measure.
- •Inaccessibility for transthoracic ultrasound diagnostics. Firstly, as described in the visit and assessment schedule (Appendix), changes in pump speed are only performed under transthoracic echo guidance. Secondly, as described above, echo parameters are required to correlate with the non-invasive CDAS pump data. Therefore, the inaccessibility of ultrasound diagnostics (e.g. due to poor image quality) is another exclusion criterion.
结局指标
主要结局
Incidence of suction events and suction burden (percentage number of suction operation in relation to normal operation) evaluated using routinely available HeartMate 3 log files and high-resolution CDAS data
时间窗: 2 years
The incidence of suction events and suction burden due to hemodynamically changes during follow-up will be evaluated with high resolution continuous data acquisition system (CDAS) data and the routinely available HeartMate 3 logfiles and compared to each other. Null hypothesis: There is no difference in the incidence of suction events and suction burden assessed by routinely available HeartMate 3 log files and high-resolution CDAS data.
次要结局
- Change of left ventricular unloading during pump speed changes (+- 20% from baseline speed)(at post operative day 3, hospital discharge and at 6 months following hospital discharge)
研究者
Thomas Schlöglhofer, PhD, MSc
Principal Investigator
Medical University of Vienna