Improving Heart Transplant Allocation to Reduce High Waitlist Mortality in Women

改善心脏移植分配以降低女性等待名单上的高死亡率

• 批准号: 9125416
• 负责人: Eileen Michelle Hsich
• 金额: $ 28.59万
• 依托单位: CLEVELAND CLINIC LERNER COM-CWRU
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-09-06 至 2017-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9125416
• 关键词: Accounting; Affect; Area; Cardiomyopathies; Cessation of life; Clinical; Complex; Databases; Equilibrium; Foundations; Future; Gender; General Population; Goals; Health; Healthcare; Hearing; Heart; Heart Transplantation; Heart failure; Kidney Transplantation; Knowledge; Lung Transplantation; Machine Learning; Mechanics; Medical Device; Methods; Mission; Modeling; National Heart, Lung, and Blood Institute; Oxygen Consumption; Patient Rights; Patients; Policies; Population; Population Characteristics; Public Health; Registries; Research; Research Design; Research Personnel; Research Proposals; Risk; Risk Factors; Sex Characteristics; Specialist; Statistical Methods; System; Systolic heart failure; Testing; Time; Transplant Recipients; Transplantation; United States; Validation; Waiting Lists; Woman; base; candidate selection; clinical practice; cohort; design; empowered; expectation; hazard; improved; innovation; liver transplantation; men; mortality; organ allocation; predictive modeling; prognostic; sex; time use; transplant registry; working group

 DESCRIPTION (provided by applicant): There is a fundamental gap in understanding why women awaiting heart transplantation have a higher mortality rate than men. The long-term goal of this project is to optimize timing and candidacy for advanced heart failure therapy in order to improve healthcare and reduce heart transplant waitlist mortality. The objective of this research application is to use a contemporary cohort to evaluate sex differences in heart transplant waitlist mortality and create a survival model that better predicts need for advanced heart failure therapy. The central hypothesis is that sex differences in heart failure mortality among patients awaiting transplantation are due to sex differences in prognostic risk factors. The rationale for the proposed research is that sex differences in prognostic risk factors have been identified in other heart failure cohorts and creation of risk prediction models has successfully reduced waitlist mortality for lung, liver, and kidney transplantation. The specific aims of this research proposal are: 1) to identify sex-specific risk factors for survival in heart failure patients awaitng heart transplantation and changes in risk factors over time using the national registry (Scientific Registry of Transplant Recipients, SRTR), 2) to develop a survival model for patients awaiting heart transplant using the SRTR database, and 3) to validate that the survival model improves prediction of mortality for the general population of patients awaiting transplantation. The approach is innovative because it challenges and seeks to shift current heart failure research and clinical practice paradigms by taking into account the differences between women and men to create a heart failure survival model that will lay the foundation to change a "rule based" hear transplant allocation system to a state of the art "survival model based" system. The survival model will be created with innovative machine learning statistical methods that do not require advance knowledge of interactions between variables or the parametric relation of variables (linearity or non-linearity) to patient survival. The proposed research is significant, because few studies have explored sex differences in prognostic risk factors despite known sex differences in heart failure survival. Furthermore, by creating the first heart failure survival model that includes sex specific risk factors and modern medical/device therapy with adequate representation of women and men we will be significantly advancing the heart failure field. This model, which is derived from our national transplant registry, will improe survival prediction for advanced heart failure patients and can be used to inform and enhance organ allocation policy in the United States. Clinical heart failure studies can also be designed i the future to include women with similar risk of mortality to men in order to improve treatment for both sexes. Ultimately, such knowledge has the potential to empower clinicians and researchers to provide the right therapies for the right patient at the right time.

 描述(由申请人提供)：在理解为什么等待心脏移植的女性的死亡率高于男性方面存在一个根本的差距。该项目的长期目标是优化先进心力衰竭治疗的时机和候选条件，以改善医疗保健并降低心脏移植等待名单上的死亡率。这项研究应用的目的是使用当代队列来评估心脏移植等待死亡率的性别差异，并创建更好地预测晚期心力衰竭需求的生存模型 心理治疗。中心假设是等待移植的患者心力衰竭死亡率的性别差异是由于预后危险因素的性别差异。提出这项研究的理由是，在其他心力衰竭队列中已经发现了预后危险因素的性别差异，风险预测模型的创建成功地降低了肺、肝和肾移植的等待死亡率。这项研究建议的具体目的是：1)利用国家登记(科学)确定等待心脏移植的心力衰竭患者存活的特定性别危险因素以及危险因素随时间的变化 移植受者登记处)，2)使用SRTR数据库为等待心脏移植的患者开发生存模型，以及3)验证生存模型改善等待移植患者的普通人群的死亡率预测。这种方法是创新的，因为它挑战并试图通过考虑男女之间的差异来改变当前的心力衰竭研究和临床实践范式，以创建心力衰竭生存模型，为将基于规则的心脏移植分配系统改变为最先进的基于生存模型的系统奠定基础。生存模型将用创新的机器学习统计方法创建，这些方法不需要预先了解变量之间的相互作用或变量(线性或非线性)与患者生存的参数关系。这项拟议的研究意义重大，因为很少有 研究探索了性别差异对预后风险的影响 尽管已知性别差异，但影响心力衰竭存活率的因素。此外，通过创建第一个 心力衰竭生存模型，包括性别特有的危险因素和现代医疗/设备治疗，充分代表女性和男性，我们将显着推进心力衰竭领域。这一模型源自我们的国家移植登记，将改善晚期心力衰竭患者的生存预测，并可用于告知和加强美国的器官分配政策。未来还可以设计临床心力衰竭研究，将死亡风险与男性相似的女性包括在内，以改善对心力衰竭的治疗 两性都有。最终，这样的知识有可能使临床医生和研究人员能够在正确的时间为正确的患者提供正确的治疗方法。

项目成果

Clinical Outcomes for Peripartum Cardiomyopathy in North America: Results of the IPAC Study (Investigations of Pregnancy-Associated Cardiomyopathy).

• DOI: 10.1016/j.jacc.2015.06.1309
• 发表时间: 2015-08-25
• 期刊: Journal of the American College of Cardiology
• 影响因子: 24
• 作者: McNamara DM;Elkayam U;Alharethi R;Damp J;Hsich E;Ewald G;Modi K;Alexis JD;Ramani GV;Semigran MJ;Haythe J;Markham DW;Marek J;Gorcsan J 3rd;Wu WC;Lin Y;Halder I;Pisarcik J;Cooper LT;Fett JD;IPAC Investigators
• 通讯作者: IPAC Investigators

Does Size Matter With Continuous Left Ventricular Assist Devices?

尺寸对于连续左心室辅助装置重要吗？

• DOI: 10.1016/j.jchf.2016.10.002
• 发表时间: 2017
• 期刊: JACC. Heart failure
• 作者: Hsich,EileenM

Advances in Cardiovascular Health in Women over the Past Decade: Guideline Recommendations for Practice.

过去十年女性心血管健康的进展：实践指南建议。

• DOI: 10.1089/jwh.2016.6316
• 发表时间: 2018
• 期刊: Journal of women's health (2002)
• 作者: Raeisi-Giglou,Pejman;Volgman,AnnabelleSantos;Patel,Hena;Campbell,Susan;Villablanca,Amparo;Hsich,Eileen
• 通讯作者: Hsich,Eileen

Matching the Market for Heart Transplantation.

• DOI: 10.1161/circheartfailure.115.002679
• 发表时间: 2016-04
• 期刊: Circulation. Heart failure
• 作者: Hsich EM

Does Survival on the Heart Transplant Waiting List Depend on the Underlying Heart Disease?

• DOI: 10.1016/j.jchf.2016.03.010
• 发表时间: 2016-09-01
• 期刊: JACC-HEART FAILURE
• 影响因子: 13
• 作者: Hsich, Eileen M.;Rogers, Joseph G.;Schold, Jesse D.
• 通讯作者: Schold, Jesse D.