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| Name | Class |
|---|---|
| Cor Aegrum Foundation of Cardiac Surgery Development in Cracow, Poland | UNKNOWN |
| Medtronic Poland Spółka z ograniczoną odpowiedzialnością | INDUSTRY |
| AGH University of Science and Technology, Krakow, Poland |
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To evaluate the concept of dynamic pump speed optimization based on the echocardiographic assessment of aortic valve opening during cardiopulmonary exercise test.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LVAD pump speed dynamically adjusted | Experimental |
| |
| LVAD pump at optimal resting speed | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cardiopulmonary exercise tests with maintained baseline optimal pump speed settings. | Other | 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. |
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maciej Stapor, MD PhD | Department of Interventional Cardiology, John Paul II Hospital | Study Director |
| Karol Wierzbicki, Assoc Prof | Department of Cardiovascular Surgery and Transplantology, John Paul II Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| John Paul II Hospital | Krakow | Lesser Poland Voivodeship | 31-202 | Poland |
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prospective crossover AB/BA study
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| Cardiopulmonary exercise test with gradually increased pump speed depending on live echocardiographic imaging. | Other | 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. |
|
| 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 |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D005080 | Exercise Test |
| ID | Term |
|---|---|
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D012129 | Respiratory Function Tests |
| D003948 | Diagnostic Techniques, Respiratory System |
| D016552 | Ergometry |
| D008919 | Investigative Techniques |
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