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局 主要研究者：Himabindu Vidula，医学博士，理学硕士 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接受左心室持续血流（CF）支持， 辅助装置（LVAD），但CF-LVAD患者的最佳血压（BP）范围 支助的性质尚待充分确定。先前对使用较旧LVAD技术的患者进行的研究 提示血压升高与不良结局相关，包括中风和死亡率。但 由当代离心泵支持的患者的最大和最小BP阈值，例如 HeartMate 3（HM 3）LVAD主要基于专家共识。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患者的最佳抗高血压药物治疗方案尚未明确。 一项来自机械辅助循环支持机构间登记处的最新研究 （INTERMACS）提示，低血压和极高血压均与CF-LVAD患者死亡率增加相关 患者，但这些回顾性分析受到仅在固定血压下进行血压测量的限制。 与不良事件发生时间无关的时间点。我们从罗切斯特大学得到的初步数据 数据库，采用310例CF-LVAD中66，618次无创BP测量的时间依赖性分析 患者，证明维持平均动脉压（MAP）低于80 mmHg与 LVAD植入后第一年内卒中或死亡风险增加。此外，我们的发现 表明最佳血压阈值存在性别和种族差异。 血压与中风或死亡的关系以前没有在一项前瞻性研究中研究过， HM 3 LVAD患者和该人群中相应的BP指南尚未明确定义。我们提出了一个 在4个不同LVAD植入中心对200例新植入HM 3 LVAD门诊患者进行的前瞻性研究。 出院后，患者将在家中测量血压，每周3天，持续6个月， 除了每周家庭血压测量和门诊血压测量的标准化方案外，还进行多普勒超声检查 在整个随访期间每3个月进行一次评估。BP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 关于低血压与中风或死亡风险相关性的研究结果，并确定适当的血压 HM 3 LVAD患者的阈值。具体目标#2是在以下条件下确定最佳BP范围： 亚组：1）女性与男性相比; 2）黑人与白色相比; 3）RHF患者与 无RHF的患者。具体目标#3是评价抗高血压药物使用与BP的相互作用 以确定LVAD患者的最佳医疗方案。这项研究的结果，使用新的方式， 家庭血压监测与预先指定的后续协议，有重要的意义，预防 LVAD患者的死亡和卒中，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