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: 10096600
• 负责人: Himabindu Vidula
• 金额: $ 60.77万
• 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 2026-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10096600
• 关键词: Adverse event; Antihypertensive Agents; 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 regulation; disability; follow-up; health care service utilization; implantation; improved; indexing; left ventricular assist device; men; mortality; novel; pressure; racial difference; 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.

当代左心室辅助设备接受者的血压和结果 PI：Misabindu Vidula，医学博士，MS 罗切斯特大学医学中心，纽约州罗切斯特 越来越多的晚期心力衰竭患者由连续流（CF）左心室支持 全球辅助设备（LVAD），但是CF-LVAD患者的最佳血压（BP）范围 支持尚未充分表征。以前对具有LVAD较旧技术患者的研究已有 建议BP升高与不良结果有关，包括中风和死亡率。但是， 当代离心流动泵支持的患者的最大和最小BP阈值，例如 Heartmate 3（HM3）LVAD主要基于专家共识。此外，存在有限的数据 BP控制的下限和女性，黑人和心力衰竭患者的BP目标（RHF）。最后， LVAD患者的最佳抗高血压药物方案的定义不当。 机械辅助循环支持的机构间注册中心的最新研究 （Intermacs）表明，低BP和非常高的BP都与CF-LVAD的死亡率增加有关 患者，但是这些回顾性分析仅受BP测量的可用性而受到限制 时间点与不良事件的时间无关。我们来自罗切斯特大学的初步数据 数据库，对310 CF-LVAD中的66,618个非侵入性BP测量进行时间依赖性分析 患者表明，保持平均动脉压（MAP）小于80 mmHg与 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 在最佳的BP阈值中提出性别和种族差异。 BP，中风或死亡的关联以前尚未在一项前瞻性研究中研究 HM3 LVAD患者以及该人群中的BP指南的定义不当。我们提出了一个 在4个不同的LVAD植入中心，对200个新植入的HM3 LVAD门诊患者进行了前瞻性研究。 索引出院后，患者将每周3天在家中测量其BP，为期6个月 多普勒超声检查除了每周家庭BP测量和临床BP的标准化方案外 整个随访每3个月进行评估。 BP将评估为时间依赖的协变量 中风或死亡的终点。我们将评估以下特定目标：特定目标＃1是验证我们的 关于低BP的关联和中风或死亡风险的发现，并确定适当的BP HM3 LVAD患者的阈值。特定目标＃2是确定以下内容的最佳BP范围 亚组：1）与男性相比； 2）黑色与白色； 3）RHF患者与 没有RHF的患者。特定目的＃3是评估抗高血压药物使用与BP的相互作用 确定LVAD患者的最佳医疗方案。这项研究的发现，使用新型的方式 使用预先指定的后续方案监测家庭BP监测，对预防具有重要意义 LVAD患者的死亡和中风将用于指导该人群不断增长的管理。