Exercise Tolerance in Patients With Implanted Left Ventricular Assist Device

To evaluate the concept of dynamic pump speed optimization based on the echocardiographic assessment of aortic valve opening during cardiopulmonary exercise test.

Study Overview

• Status: Completed
• Conditions: Left Ventricular Assist Device
• Intervention / Treatment: Other: Cardiopulmonary exercise test with gradually increased pump speed depending on live echocardiographic imaging.; Other: Cardiopulmonary exercise tests with maintained baseline optimal pump speed settings.

Detailed Description

Left ventricular assist devices (LVAD) are becoming a destination therapy in patients with end-stage left ventricular dysfunction. Current generation pumps operate with a fixed rotation speed without the capability of automated speed adjustment. It was shown that acceleration of the pump speed during stress test increases the maximum exercise tolerance. Periodic aortic valve opening (AVO) is used to set up an optimal resting pump speed. The study aimed to evaluate the concept of dynamic pump speed optimization based on the echocardiographic assessment of AVO during the cardiopulmonary exercise test (CPET).

Patients with implanted third-generation LVADs with hydrodynamic bearing (HVAD, Medtronic, MN, USA) are prospectively enrolled. Two CPETs are performed after resting speed optimization. The first one with maintained baseline pump speed settings, and the second one with gradually increased speed depending on live echocardiographic imaging. The sequence of tests is random.

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Lesser Poland
    • Krakow, Lesser Poland, Poland, 31-202
      • John Paul II Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients with implanted cardioverter-defibrillator and third-generation centrifugal CF-LVAD with hydrodynamic bearing (HVAD, Medtronic, Minnesota, United States), at least three months after surgery.

Exclusion Criteria:

• Hemodynamic instability.
• Non-therapeutic anticoagulation.
• Device or intracardiac thrombus.
• Inflammation.
• Active bleeding.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LVAD pump speed dynamically adjusted	Other: Cardiopulmonary exercise test with gradually increased pump speed depending on live echocardiographic imaging.; During the modified speed exercise, when the aortic valve opening ratio rises above 50%, the pump speed is increased by 100 revolutions per minute (RPM). As the aortic valve remains closed the RPM is lowered by 100. Speed increment is not greater than 100 RPM per 45 seconds to enable an echocardiographic analysis of resulting changes and prevent suction events. There is no determined target speed, neither per time period nor maximal.
Active Comparator: LVAD pump at optimal resting speed	Other: Cardiopulmonary exercise tests with maintained baseline optimal pump speed settings.; Optimal resting LVAD speed settings is defined as periodic aortic valve opening while maintaining the central position of the intraventricular septum, minimizing mitral regurgitation, and preserving the mean systemic blood pressure above 65 mmHg. The aim is to achieve an aortic valve opening ratio of around 25-33% by changing the pump speed at resting conditions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Echocardiographic appraisal of aortic valve opening during cycle ergometer exercise.	Assessment of aortic valve opening during cycle ergometer exercise in LVAD patients.	Immediately, during cycle ergometer exercise

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in oxygen consumption	By using the cardiopulmonary exercise test	Immediately, during cycle ergometer exercise
Change in perceived exertion	By using the Borg rating of perceived exertion scale. Score 6-20 (6 - no exertion, 20 - maximal exertion)	Immediately, during cycle ergometer exercise
Change in pump speed	By assessing pump speed (RPM)	Immediately, during cycle ergometer exercise.
Change in pump flow	By assessing pump flow (l/min)	Immediately, during cycle ergometer exercise
Change in pump power	By assessing pump power (W)	Immediately, during cycle ergometer exercise

Collaborators and Investigators

• Sponsor: Karol Wierzbicki
• Collaborators: Medtronic Poland Spółka z ograniczoną odpowiedzialnością; Cor Aegrum Foundation of Cardiac Surgery Development in Cracow, Poland; AGH University of Science and Technology, Krakow, Poland
• Investigators: Study Director: Maciej Stapor, MD PhD, Department of Interventional Cardiology, John Paul II Hospital; Principal Investigator: Karol Wierzbicki, Assoc Prof, Department of Cardiovascular Surgery and Transplantology, John Paul II Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2017
• Primary Completion (Actual): July 31, 2020
• Study Completion (Actual): August 4, 2020

Study Registration Dates

• First Submitted: September 16, 2021
• First Submitted That Met QC Criteria: September 22, 2021
• First Posted (Actual): September 30, 2021

Study Record Updates

• Last Update Posted (Actual): October 21, 2021
• Last Update Submitted That Met QC Criteria: October 19, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: left ventricular assist device; heart failure; stress echocardiography; cardiopulmonary exercise test; mechanical circulatory support; peak VO2
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Dopamine Agents; Dopamine Uptake Inhibitors; Central Nervous System Stimulants; Sympathomimetics; Adrenergic Uptake Inhibitors; Methamphetamine
• Other Study ID Numbers: NB.0710.003.2021P

Drug and device information, study documents

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