LVAD Index and Clinical Outcomes in Continuous-Flow LVAD Patients (LVAD-INDEX)

Association of LVAD Index With Selected Hepatic and Renal Biochemical Markers and Rehospitalization in HVAD and HeartMate 3 Continuous-Flow Left Ventricular Assist Devices

This single-center, observational study evaluated the LVAD index, defined as device-estimated pump flow divided by body surface area, in adult patients supported with continuous-flow left ventricular assist devices. The study included 34 patients with end-stage heart failure who had either an HVAD or HeartMate 3 device and were followed for six months. The study assessed the relationship between LVAD index and selected routine biochemical markers related to hepatic and renal status, including ALT, AST, LDH, BUN, and creatinine. The study also evaluated whether LVAD index was associated with rehospitalization during follow-up.

Study Overview

• Status: Completed
• Conditions: Left Ventricular Assist Device; End-stage Heart Failure; Mechanical Circulatory Support
• Intervention / Treatment: Device: HeartWare Ventricular Assist Device; Device: HeartMate 3 Left Ventricular Assist Device

Detailed Description

This observational cohort study included adult patients with end-stage heart failure supported with continuous-flow left ventricular assist devices. Patients with HVAD and HeartMate 3 devices were followed during routine clinical visits over a six-month period. Device-estimated pump flow, power consumption, and LVAD index were recorded at follow-up visits. LVAD index was calculated as device-estimated pump flow divided by body surface area. Routine laboratory parameters, including ALT, AST, LDH, BUN, and creatinine, were evaluated as selected biochemical markers related to hepatic and renal status and tissue injury. Rehospitalization status during follow-up was also assessed. The study did not assign participants to any intervention and did not include protocol-driven pump speed adjustment.

• Study Type: Observational
• Enrollment (Actual): 34

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Antalya, Turkey (Türkiye), 07070
    • Akdeniz University Faculty of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult patients with end-stage heart failure who underwent first-time continuous-flow left ventricular assist device implantation and were followed for at least six months. The study population included patients supported with either HVAD or HeartMate 3 devices during routine clinical follow-up.

Description

Inclusion Criteria:

• Age 18 years or older
• Diagnosis of end-stage heart failure
• First-time continuous-flow left ventricular assist device implantation
• Implanted with either an HVAD or HeartMate 3 left ventricular assist device
• Minimum follow-up period of six months

Exclusion Criteria:

• Incomplete data
• Declined participation
• HeartMate II pump implantation
• Significant aortic valve dysfunction, including moderate or severe aortic regurgitation or stenosis

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
HVAD Group; Patients supported with the HeartWare Ventricular Assist Device.	Device: HeartWare Ventricular Assist Device; Patients in this group were supported with the HeartWare Ventricular Assist Device as part of routine clinical care. No device assignment or protocol-driven intervention was performed by the study investigators.
HeartMate 3 Group; Patients supported with the HeartMate 3 left ventricular assist device.	Device: HeartMate 3 Left Ventricular Assist Device; Patients in this group were supported with the HeartMate 3 left ventricular assist device as part of routine clinical care. No device assignment or protocol-driven intervention was performed by the study investigators.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Association Between LVAD Index and Selected Biochemical Markers	The association between LVAD index and selected routine biochemical markers, including ALT, AST, LDH, BUN, and creatinine, was evaluated during six-month follow-up. LVAD index was calculated as device-estimated pump flow divided by body surface area.	Six months

Collaborators and Investigators

• Sponsor: Gaziantep City Hospital
• Collaborators: Akdeniz University Hospital; Antalya City Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2022
• Primary Completion (Actual): April 30, 2023
• Study Completion (Actual): April 30, 2023

Study Registration Dates

• First Submitted: June 2, 2026
• First Submitted That Met QC Criteria: June 2, 2026
• First Posted (Actual): June 8, 2026

Study Record Updates

• Last Update Posted (Actual): June 8, 2026
• Last Update Submitted That Met QC Criteria: June 2, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Rehospitalization; HeartMate 3; LVAD Index; Continuous-Flow Left Ventricular Assist Device; HVAD; Pump Flow
• Other Study ID Numbers: LVADIDX2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be publicly shared due to patient confidentiality and institutional data protection requirements. De-identified data may be made available from the corresponding author upon reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No