TY - JOUR
T1 - Impact of Hemodynamic Ramp Test-Guided HVAD Speed and Medication Adjustments on Clinical Outcomes
T2 - The RAMP-IT-UP Multicenter Study
AU - Uriel, Nir
AU - Burkhoff, Daniel
AU - Rich, Jonathan D.
AU - Drakos, Stavros G.
AU - Teuteberg, Jeffrey J.
AU - Imamura, Teruhiko
AU - Rodgers, Daniel
AU - Raikhelkar, Jayant
AU - Vorovich, Esther E.
AU - Selzman, Craig H.
AU - Kim, Gene
AU - Sayer, Gabriel
N1 - Funding Information:
Dr Imamura receives financial support from Teraura-Sayoko Memorial Scholarship Foundation. Dr Uriel receives grant support from Medtronic and is a consultant of Medtronic. Dr Sayer is a consultant for Medtronic. Dr Rich is a consultant of Medtronic. Dr Teuteberg is a member of the advisory board and receives speaking fees from Medtronic. The other authors report no conflicts.
Publisher Copyright:
© 2019 American Heart Association, Inc.
PY - 2019/4/1
Y1 - 2019/4/1
N2 - 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.
AB - 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.
KW - echocardiography
KW - heart failure
KW - hemodynamics
KW - mortality
KW - survival
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U2 - 10.1161/CIRCHEARTFAILURE.119.006067
DO - 10.1161/CIRCHEARTFAILURE.119.006067
M3 - Article
C2 - 30946600
AN - SCOPUS:85064316203
SN - 1941-3289
VL - 12
JO - Circulation: Heart Failure
JF - Circulation: Heart Failure
IS - 4
M1 - e006067
ER -