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: 10855889
• 负责人: Himabindu Vidula
• 金额: $ 62.76万
• 依托单位: UNIVERSITY OF PENNSYLVANIA
• 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/10855889
• 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; Specific qualifier value; Standardization; Stress; Stroke; Structure; Subgroup; Technology; Thrombosis; Time; Universities; Woman; adverse outcome; 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.

当代左心室辅助装置接受者的血压和结果 PI：Himabindu Vidula，医学博士、硕士 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得到连续流 (CF) 左心室的支持 世界各地都有辅助装置 (LVAD)，但 CF-LVAD 患者的最佳血压 (BP) 范围 支持尚未完全确定。先前对接受旧 LVAD 技术的患者的研究表明 表明血压升高与不良后果相关，包括中风和死亡。然而， 由当代离心流量泵支持的患者的最大和最小血压阈值，例如 HeartMate 3 (HM3) LVAD 很大程度上基于专家共识。此外，关于 女性、黑人和右心衰竭 (RHF) 患者的血压控制和血压目标的下限。最后， LVAD 患者的最佳抗高血压药物治疗方案尚未明确。 机械辅助循环支持机构间登记处最近的一项研究 (INTERMACS) 表明，低血压和极高血压均与 CF-LVAD 死亡率增加相关 患者，但这些回顾性分析受到血压测量仅在固定时间可用的限制。 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，对 310 CF-LVAD 中的 66,618 个无创血压测量值进行时间相关分析 患者，证明维持平均动脉压 (MAP) 低于 80 mmHg 与 LVAD 植入后第一年中风或死亡的风险增加。此外，我们的发现 表明最佳血压阈值存在性别和种族差异。 此前尚未在前瞻性研究中研究过血压与中风或死亡的关联 HM3 LVAD 患者以及该人群相应的血压指南尚未明确定义。我们提出一个 对 4 个不同 LVAD 植入中心的 200 名新植入 HM3 LVAD 门诊患者的前瞻性研究。 出院后，患者将每周 3 天在家测量血压，为期 6 个月。 多普勒超声以及每周家庭血压测量和诊所血压的标准化方案 整个随访过程中每 3 个月进行一次评估。血压将被评估为时间依赖性协变量 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 有关低血压与中风或死亡风险之间关系的研究结果，并确定适当的血压 HM3 LVAD 患者的阈值。具体目标#2 是确定以下最佳血压范围 亚组：1）女性与男性相比； 2）黑人与白人； 3) 与 RHF 患者相比 无 RHF 的患者。具体目标#3是评估抗高血压药物的使用与血压的相互作用 确定 LVAD 患者的最佳治疗方案。这项研究的结果，使用新颖的方式 通过预先指定的后续方案进行家庭血压监测对于预防高血压具有重要意义 LVAD 患者的死亡和中风，并将用于指导这一不断增长的人群的管理。

项目成果

Low Blood Pressure Threshold for Adverse Outcomes During Left Ventricular Assist Device Support.

左心室辅助装置支持期间不良结果的低血压阈值。

• DOI: 10.1016/j.amjcard.2021.12.045
• 发表时间: 2022
• 期刊: The American journal of cardiology
• 作者: Vidula,Himabindu;Altintas,Onur;McNitt,Scott;DeVore,AdamD;Birati,EdoY;Genuardi,MichaelV;Sheikh,FarooqH;Polonsky,Bronislava;Alexis,JeffreyD;Gosev,Igor;Bisognano,JohnD;Kutyifa,Valentina;Seidmann,Abraham;Goldenberg,Ilan
• 通讯作者: Goldenberg,Ilan