Exploration of Intracardiac Geometry and Hemodynamics During HeartMate 3 Therapy: A Novel Approach Using Photon-Counting CT and Computational Fluid Dynamics
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Intracardiac Geometry
研究概览
简要总结
The goal of this observational study is to exploratively investigate intracardiac geometry and hemodynamics in patients with ongoing HeartMate 3-therapy in the Swedish Southeast Healthcare region. The main question it aims to answer is:
- How do different flow levels in the HeartMate 3 left ventricular assist system influence intracardiac geometry and hemodynamics?
Participating research subjects are called upon to undergo three followed photon-counting CT scans, as well as certain echocardiographic imaging, all in one session. The research subject's HeartMate device is connected to software that allows for variations in the pump's flow between these image collections. Analyzed variables includes three-dimensional geometry, CFD-computed parameters such as blood velocity, pressure, turbulence, and blood stasis. The variables are related with device settings and, alongside, selected echocardiographic measurements and patient details such as age, BMI, and diagnostic codes for both method validation and comprehensive perspective.
详细描述
- BACKGROUND
In recent years, the use of the mechanical circulatory support device, HeartMate 3 (HM3) (Abbott Laboratories, Lake Forest, IL), has garnered significant attention in the realm of circulatory support for advanced heart failure. The tangible advantages of the HM3, including enhanced hemocompatibility leading to reduced thromboembolic events and improved survival rates compared to its predecessors. The transition towards HM3 is particularly noteworthy as the system is not only likely to serve as a bridge to heart transplantation or decision-making but is increasingly being discussed as an effective destination therapy. Despite these advancements, there remains an imperative for meticulous hemodynamic monitoring throughout any mechanical circulatory support treatment. Traditionally, echocardiography has been predominantly employed as the hemodynamic imaging modality. However, echocardiographic evaluations of these patients present notable challenges, especially concerning shadows from the pump's metal, making it difficult to fully comprehend cardiac function and hemodynamics during the treatment.
Over the past decade, computed tomography (CT) has seen rapid advancements, with modern equipment now facilitating high-resolution anatomical imaging of the heart throughout the cardiac cycle (4D CT). Until recently, however, CT also posed a challenge for the examination of patients with mechanical circulatory support devices due to significant metal artifacts. The newly introduced photon-counting computed tomography (PC-CT), however, now enables scans that yield higher resolution images with reduced metal artifacts. From time-resolved CT, functional information can subsequently be derived and extracted. Techniques for automatic tracking of cardiac wall motion throughout the cardiac cycle, along with the utilization of computational dynamics to numerically solve fluid mechanical equations have previously been shown, which have proven to enable simulations of intracardiac hemodynamic maps.
The increasing indications for treatment with mechanical circulatory support underscore the current demand for continuously improved care quality and clinical understanding of this therapeutic option. Although the treatment enhances both prognosis and quality of life, serious and fatal complications remain recurrent. To the knowledge of the investigators, there has yet been no conducted research addressing the potential application of the novel PC-CT in patients with mechanical circulatory support devices, and certainly none that have established numerical frameworks on this data in an attempt to compute, visualize, and exploratively understand intracardiac hemodynamics during the treatment.
1.2 OBJECTIVES
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
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
- •Connected to Linköping University Hospital ((situated in the Swedish Southeastern healthcare region)
- •Treatment with HeartMate 3 and implanted for > 6 months ago
- •Age >18 years.
排除标准
- •Reduced kidney function (eGFR below 45 ml/min/1.73m2).
- •Known iodine contrast allergy
- •In case of untreated manifest hyperthyroidism
- •In case of suspected/newly diagnosed thyroid cancer where radioiodine examination/treatment may be relevant
- •Myasthenia Gravis
- •Ongoing pregnancy
结局指标
主要结局
Intracardiac Geometry
时间窗: Observations are made at a single point in time. No follow-up of outcomes are analyzed. Post-processing and analysis of both hemodynamic and geometric data are performed through study completion, an average of 1 year.
Intracardiac volumes (ml) will be calculated for the left atrium, left ventricle, right ventricle and right atrium over the cardiac cycle (20 phases). It is essential to clarify that due to the exploratory nature of the research and the intricate dynamics inherent to both using numerical frameworks for calculating intracardiac hemodynamic maps and the dynamic geometric nature of time-resolved CT, all variables at the study onset are not pre-defined. As the analysis progresses, and the full depth of the data becomes apparent, additional variables may be identified and incorporated. Subsequent decision-making process relating to the inclusion or exclusion of these newly discovered variables will be rigorously documented to ensure transparency and robustness in the study approach.
Hemodynamic Variables
时间窗: Observations are made at a single point in time. No follow-up of outcomes are analyzed. Post-processing and analysis of both hemodynamic and geometric data are performed through study completion, an average of 1 year.
Intracardiac hemodynamic variables such as blood flow velocity maps (m/s), absolute pressure maps (mmHg), turbulence kinetic energy maps (TKE), and blood stasis maps will be calculated both intracardiac and in the pump's outflow graft. It is essential to clarify that due to the exploratory nature of the research and the intricate dynamics inherent to both using numerical frameworks for calculating intracardiac hemodynamic maps and the dynamic geometric nature of time-resolved CT, all variables at the study onset are not pre-defined. As the analysis progresses, and the full depth of the data becomes apparent, additional variables may be identified and incorporated. Subsequent decision-making process relating to the inclusion or exclusion of these newly discovered variables will be rigorously documented to ensure transparency and robustness in the study approach.
次要结局
未报告次要终点
研究者
Hans Granfeldt
Senior consultant, cardiothoracic surgery (MD/PhD), deputy operational manager
Region Östergötland
