Optimal Decision Making in Aortic Valve Replacement

主动脉瓣置换术的最佳决策

基本信息

批准号：
8635238
负责人：
Suzanne Victoria Arnold
金额：
$ 12.29万
依托单位：
SAINT LUKE'S HOSPITAL
依托单位国家：
美国
项目类别：
财政年份：
2014
资助国家：
美国
起止时间：
2014-05-01 至 2019-04-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8635238
关键词：
Aftercare Aortic Valve Stenosis Back Benefits and Risks Blood Vessels Cardiac Surgery procedures Cardiovascular Diseases Caring Cessation of life Characteristics Clinic Clinical Clinical Trials Comorbidity Data Decision Making Disease Economic Models Economics Elderly Emerging Technologies Evaluation Frail Elderly Goals Health Care Costs Health Care Reform Healthcare Heart Valve Diseases Heterogeneity Individual Intervention Life Expectancy Living Costs Longevity Medical Medical Technology Methods Modeling Online Systems Operative Surgical Procedures Outcome Outpatients Patients Policies Policy Maker Population Procedures Prospective Studies Public Policy Quality of Care Quality of life Randomized Research Infrastructure Risk Stroke Technology Testing Time Vision adverse outcome alternative treatment aortic valve replacement base care preference career career development clinical care cost cost effective cost effectiveness data modeling economic cost evidence base experience feeding improved innovation interest mortality novel older patient patient oriented patient population programs public health relevance response shared decision making tool treatment effect valve replacement

项目摘要

DESCRIPTION (provided by applicant): Aortic stenosis is a highly prevalent disease among elderly patients and causes reduced life expectancy, poor quality of life (QoL), and increased healthcare costs. In the setting of severe, symptomatic aortic stenosis, valve replacement is the mainstay of treatment, which has traditionally meant open-heart surgery. Recently, transcatheter aortic valve replacement (TAVR) has emerged as a less-invasive approach to valve replacement, and is particularly attractive in elderly patients with multiple comorbidities. n the Placement of AoRTic TraNscathetER Valve (PARTNER) Trial, which randomized patients too ill to undergo surgery to medical therapy or TAVR, TAVR patients had improved survival and better QoL than those receiving medical therapy alone. Despite the benefits of TAVR, nearly 1/3 were dead within 1 year of treatment, and approximately half did not benefit from TAVR (either dead or no QoL improvement at 1 year). Given the upfront risks and costs of TAVR, identifying patients, prior to the procedure, who are unlikely to benefit can enable patients and practitioners to make a more informed decision about whether or not to undergo the procedure. Using data from the PARTNER trial and other ongoing prospective studies, we will build economic and QoL prediction models to support the most efficient use of this emerging technology. In order to accomplish these goals, we plan to use both multivariable statistical and decision analytic models of survival, QoL and costs try to clarify the potential risks and benefits of particular patients undergoing TAVR, thus quantifying the heterogeneity of treatment benefits and enabling these estimates to be calculated on a patient-by-patient basis. We then plan to feed this information back to patients and practitioners at the time when the treatment decision is being made using a novel web-based technology that can generate individualized estimates of patients' predicted risks and outcomes. These estimates of clinical outcomes (e.g. QoL) can then be incorporated into patient-specific shared decision-making tools. Providing these data prospectively to patients and practitioners will support a novel dialogue, based on the evidence-based, projected outcomes of the individual patient. In addition, the economic models can support policy decisions that allocate TAVR in the most cost-effective manner. Altogether, these studies will allow for the most effective and efficient application of this exciting and innovative medical technology.

描述（由申请人提供）：主动脉瓣狭窄是老年患者中一种非常普遍的疾病，会导致预期寿命缩短、生活质量 (QoL) 差以及医疗费用增加。在严重、有症状的主动脉瓣狭窄的情况下，瓣膜置换术是主要的治疗方法，传统上意味着心脏直视手术。最近，经导管主动脉瓣置换术（TAVR）已成为一种微创瓣膜置换术，对患有多种合并症的老年患者特别有吸引力。在主动脉导管瓣膜置入 (PARTNER) 试验中，将因病情太重而无法接受手术的患者随机分配至药物治疗或 TAVR 组，结果发现 TAVR 患者比仅接受药物治疗的患者生存率更高，生活质量更好。尽管 TAVR 有好处，但近 1/3 的患者在治疗后 1 年内死亡，大约一半的患者没有从 TAVR 中受益（一年内死亡或生活质量没有改善）。考虑到 TAVR 的前期风险和成本，在手术前识别不太可能受益的患者可以使患者和医生能够就是否接受该程序做出更明智的决定。利用 PARTNER 试验和其他正在进行的前瞻性研究的数据，我们将建立经济和生活质量预测模型，以支持最有效地利用这一新兴技术。为了实现这些目标，我们计划使用生存、生活质量和成本的多变量统计和决策分析模型，试图阐明接受 TAVR 的特定患者的潜在风险和益处，从而量化治疗益处的异质性并使这些估计能够是根据每个病人的情况来计算的。然后，我们计划在使用一种新颖的基于网络的技术做出治疗决定时将这些信息反馈给患者和医生，该技术可以生成患者预测风险和结果的个性化估计。然后可以将这些临床结果（例如生活质量）的估计纳入患者特定的共享决策工具中。前瞻性地向患者和从业者提供这些数据将支持基于个体患者的循证预测结果的新颖对话。此外，经济模型可以支持以最具成本效益的方式分配 TAVR 的政策决策。总而言之，这些研究将使这一令人兴奋和创新的技术得到最有效和高效的应用。医疗技术。