Blood Pressure and Outcomes in Contemporary Left Ventricular Assist Device Recipients

当代左心室辅助装置接受者的血压和结果

• 批准号: 10428457
• 负责人: Himabindu Vidula
• 金额: $ 57.65万
• 依托单位: UNIVERSITY OF ROCHESTER
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-06-15 至 2023-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10428457
• 关键词: Adverse event; Antihypertensive Agents; Black Populations; Black race; Blood Pressure; Blood Pressure Monitors; Brain hemorrhage; Cardiomyopathies; Cessation of life; Cities; Clinic; Clinical; Consensus; Data; Databases; Development; Devices; Doppler Ultrasound; Generations; Glomerular Filtration Rate; Goals; Guidelines; Health; Heart failure; Home; Home Blood Pressure Monitoring; Hypertension; Hypotension; Implant; Interagency Registry for Mechanically Assisted Circulatory Support; Ischemic Stroke; Kansas; Magnetism; Measurement; Measures; Mechanics; Medical; Medical center; Modality; Outcome; Outpatients; Patient Outcomes Assessments; Patients; Pharmaceutical Preparations; Population; Prevention; Prospective Studies; Protocols documentation; Pump; Quality of life; Questionnaires; Regimen; Renal function; Risk Factors; Sex Differences; Standardization; Stress; Stroke; Structure; Subgroup; Technology; Thrombosis; Time; Universities; Woman; adverse outcome; base; black patient; blood pressure control; blood pressure elevation; disability; follow-up; health care service utilization; implantation; improved; indexing; left ventricular assist device; men; mortality; novel; pressure; racial difference; right ventricular failure; stroke risk

Blood Pressure and Outcomes in Contemporary Left Ventricular Assist Device Recipients PI: Himabindu Vidula, MD, MS University of Rochester Medical Center, Rochester, NY A growing number of advanced heart failure patients are supported by a continuous-flow (CF) left ventricular assist device (LVAD) around the world, but the optimal blood pressure (BP) range for patients on CF-LVAD support has yet to be fully characterized. Previous studies of patients with older LVAD technology have suggested that elevated BP is associated with adverse outcomes, including stroke and mortality. However, the thresholds for maximal and minimal BP for patients supported by contemporary centrifugal flow pumps, such as the HeartMate 3 (HM3) LVAD, are largely based on expert consensus. In addition, limited data exist regarding the lower limit for BP control and BP goals for women, Blacks, and patients with right heart failure (RHF). Finally, the optimal anti-hypertensive medication regimen for LVAD patients is not well defined. A recent study from the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) suggested that both low and very high BP are associated with increased mortality in CF-LVAD patients, but these retrospective analyses were limited by the availability of BP measurements only at fixed timepoints unrelated to the time of the adverse event. Our preliminary data from the University of Rochester Database, employing time-dependent analysis of 66,618 non-invasive BP measurements in 310 CF-LVAD patients, demonstrate that maintaining mean arterial pressure (MAP) less than 80 mmHg is associated with increased risk of stroke or death during the first year after LVAD implantation. Furthermore, our findings suggest a sex and racial difference in optimal BP thresholds. The association of BP and stroke or death has not been previously studied in a prospective study of HM3 LVAD patients and accordingly BP guidelines in this population are not well defined. We propose a prospective study of 200 newly implanted HM3 LVAD outpatients at 4 different LVAD implantation centers. Following index discharge, patients will measure their BP at home 3 days a week for a 6-month period with a Doppler ultrasound in addition to a standardized protocol of weekly home BP measurements and in-clinic BP assessment every 3 months throughout follow-up. BP will be assessed as a time-dependent covariate for the endpoint of stroke or death. We will evaluate the following specific aims: Specific aim #1 is to validate our findings regarding the association of low BP and the risk of stroke or death and to identify appropriate BP thresholds in HM3 LVAD patients. Specific aim #2 is to determine the optimal BP range in the following subgroups: 1) women as compared to men; 2) Black vs. White; and 3) patients with RHF as compared to patients without RHF. Specific aim #3 is to evaluate the interaction of anti-hypertensive medication use with BP to identify the optimal medical regimen for LVAD patients. Findings from this study, using novel modalities of home BP monitoring with a prespecified follow-up protocol, have important implications for the prevention of death and stroke in LVAD patients and will be used to guide management in this growing population.

现代左心辅助装置接受者的血压和预后 Pi：Himabindu Vidula，医学博士，MS 罗切斯特大学医学中心，罗切斯特，纽约 越来越多的晚期心力衰竭患者由持续血流(CF)左心室支持 世界各地的辅助装置(LVAD)，但CF-LVAD患者的最佳血压(BP)范围 支持的特征尚未完全确定。之前对使用较老的LVAD技术的患者进行的研究 提示血压升高与不良后果有关，包括中风和死亡率。然而， 当代离心泵支持的患者的最大和最小血压阈值，例如 心跳3号(HM3)LVAD，主要是基于专家的共识。此外，关于以下方面的数据有限 女性、黑人和右心衰竭(RHF)患者的血压控制下限和血压目标。最后， LVAD患者的最佳降压用药方案尚未明确。 机构间登记处最近对机械辅助循环支持的一项研究 (Intermacs)提示，低血压和极高血压都与CF-LVAD死亡率增加有关 但这些回溯性分析仅限于固定的血压测量。 与不良事件发生时间无关的时间点。我们来自罗切斯特大学的初步数据 数据库，使用310个CF-LVAD中66,618个无创性血压测量的时间依赖分析 患者的研究表明，维持平均动脉压(MAP)低于80毫米汞柱与 在LVAD植入后的第一年，中风或死亡的风险增加。此外，我们的发现 建议在最佳血压阈值上存在性别和种族差异。 BP与中风或死亡的关系以前没有在一项前瞻性研究中被研究过 HM3 LVAD患者和这一人群中的BP指南没有很好的定义。我们提出了一个 4个不同LVAD植入中心200例新植入HM3 LVAD门诊患者的前瞻性研究 在指数出院后，患者将每周三天在家中测量他们的血压，为期6个月，并进行 除了每周家庭血压测量和门诊血压测量的标准化方案外，还有多普勒超声 在整个随访过程中每3个月进行一次评估。BP将被评估为时间依赖的协变量，用于 中风或死亡的终点。我们将评估以下具体目标：具体目标1是验证我们的 关于低血压与中风或死亡风险的关系的研究结果，并确定适当的BP HM3 LVAD患者的阈值。具体目标#2是在以下方面确定最佳BP范围 亚组：1)女性与男性的比较；2)黑人与白人的比较；以及3)风湿性心衰患者与 未发生RHF的患者。具体目标#3是评估抗高血压药物使用与BP的相互作用 目的：探讨左冠状动脉前降支患者的最佳用药方案。这项研究的发现，使用了新的模式 家庭血压监测与预先指定的随访方案，对预防高血压具有重要意义 这项研究将用于指导这一不断增长的人群的治疗。