Impact of Hemodynamic Ramp Test-Guided HVAD Speed and Medication Adjustments on Clinical Outcomes

Abstract

Background: Hemodynamic ramp (HR) tests can guide the optimization of left ventricular assist device (LVAD) speed and direct medical therapy. We investigated the effects of HR-guided LVAD management. Methods and Results: This prospective, multicenter, randomized, pilot study compared outcomes in LVAD patients using an HR-guided (HR group) versus a standard transthoracic echocardiography-guided (control group) management strategy. Patients were enrolled and randomized 1 to 3 months post-HVAD implantation and followed for 6 months. Twenty-two patients (57±10 years, 73% male) were randomized to the HR group and 19 patients (51±13 years, 63% male) to the control group. HR group patients had double the number of LVAD speed changes (1.68 versus 0.84 changes/patient, P =0.09 with an incidence rate ratio 2.0, 95% CI, 0.9–4.7) with twice the magnitude of rotations per minute changes (130 versus 60 rotations per minute/patient, P =0.004) during the study. The HR group also had 2-fold greater heart failure medication changes (4.32 versus 2.53 changes/patient, P =0.072, incidence rate ratio 1.7 with 95% CI, 0.8–3.5) predominantly because of changes in diuretic dose (40 versus 0 mg/patient, P <0.001). The HR group had numerically but not statistically higher event-free survival (62% versus 46%, P =0.087; hazard ratio, 0.46 with 95% CI, 0.2–1.2), with numerically but not statistically lower events per patient-year ( P =0.084). There were no significant differences in the 6-minute walk or Kansas City Cardiomyopathy Questionnaire tests at 6 months. Conclusions: In this randomized pilot study of LVAD patient management we demonstrated the feasibility of standardized HR testing at multiple institutions and that a strategy guided by hemodynamics was associated with more LVAD speed and medication adjustments and a nonsignificant reduction in adverse events. A pivotal study to demonstrate the clinical benefit of HR testing is warranted. Clinical Trial Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT03021239.

Comment on: Implication of pulmonary artery pressure monitoring during left ventricular assist device supports

“…We fully agree that the PAP‐guided adjustment of LVAD speed and medications would likely result in a reduction in HF readmissions, given the strongly positive studies previously published on the use of CardioMEMS in general HF cohorts . If the CardioMEMS device can be mechanistically linked to LVADs, the promising future of a smart pump, which can automatically adjust pump settings based on feedback from the CardioMEMS, would be a welcomed innovation. Unique hemodynamic challenges remain nevertheless in estimating the degree of ventricular unloading, as approximately half of clinically stable LVAD patients have decoupling between diastolic PAP and pulmonary capillary wedge pressure …”

“…We read with great interest the protocol design of HEMO‐VAD pilot study proposed by Veenis and colleagues, in which the feasibility and implication of pulmonary artery pressure (PAP) guidance with CardioMEMS in patients with left ventricular assist device (LVAD) is prospectively investigated. Our team recently demonstrated the implications of hemodynamic optimization in LVAD patients, with the observed association of abnormal hemodynamics and heart failure (HF) readmissions along with hemocompatibility‐related adverse events …”

Perioperative improvement in serum albumin level in patients with left ventricular assist device

“…Furthermore, given the complexity of the mechanism, simple supplementation of calories is not sufficient to improve cardiac cachexia. 24 Hemodynamic optimization via ramp test, 22 intravenous administration of testosterone to improve skeletal muscle wasting, 25 oral administration of omega-3 fatty acid to suppress chronic inflammation, 26 and cardiac rehabilitation might be effective to improve cardiac cachexia in LVAD patients. 27 Note: Variables were expressed as median and interquartile and compared between the groups using Mann-Whitney U test.…”

Measurements of liver stiffness in patients with left ventricular assist device support

“…Recently, Dr. Imamura and colleagues reported that aggressive hemodynamic optimization by right heart catheterization reduced various comorbidities and hospital readmission in LVAD patients [5,6]. Nevertheless, routine or repeated use of invasive hemodynamic assessment would not be recommended because of its specific complications such as infection, hemorrhage and its expensive medical cost as mentioned.…”