Central and Cerebral Circulation in Early Stages After LVAD Implantation

Heart Failure, Left-Sided Clinical Trial

— ECOH3  

Official title:

Evaluation of Central and Cerebral Circulation in Early Stages After Implantation of Left Ventricular Assist Device (LVAD)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03087669
• Other study ID #: ECOH 3
• Status: Recruiting
• Phase: N/A
• First received: February 28, 2017
• Last updated: March 21, 2017
• Start date: February 16, 2017
• Est. completion date: March 1, 2020

Study information

• Verified date: March 2017
• Source: Sahlgrenska University Hospital, Sweden
• Contact: Bengt Redfors, MD.PhD
• Phone: 0046313427445
• Email: bengt.redfors[@]vgregion.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This trial will evaluate patients with a mechanical Left Ventricular Assist Device (LVAD) in early stages after surgical implantation. Within the first 2 days of postoperative ICU care, 20 patients will firstly be exposed to 4 different LVAD pump flow settings with a stable blood pressure. A second intervention will be mean arterial blood pressure (MAP) adjustments to 4 preset levels (60-70-80 and 90 mmHg) with a constant preset LVAD flow. The two manipulations; 1) Constant MAP with variation of LVAD flow and 2) Constant LVAD flow with variation of MAP, will be monitored by Central hemodynamic parameters, echocardiographic parameters and cerebral blood flow velocity (CBFV) parameters. The purpose of the trial is to find the optimal combination of LVAD pump flow, mean arterial pressure and right heart ventricle function for each patient. And at the same time describe the effect of flow and pressure variations on CBFV.

Description:

Patients with severe left ventricular heart failure and estimated short expected survival time despite optimal medical therapy can be treated with a left ventricular mechanical heart pump - described as a Left Ventricular Assist Device (LVAD). The LVAD can be used as a bridge for patient survival prior to heart transplantation, or as a destination therapy for terminal heart failure. The LVAD delivers a non-pulsatile blood flow into the patients aorta, supporting and/or taking over the left ventricular function. However the right heart ventricle (RV) is not supported by the LVAD. RV failure is a major threat to the patient, in particular during the early postoperative period. Postoperative RV failure after LVAD implantation is medically treated, but in severe cases a mechanical temporary right ventricular assist (RVAD) may be needed. Patients in need of postoperative RVAD after an LVAD implant have a significantly increased mortality. Thus it is of vital importance to balance the LVAD pump flow against the native RV function in order to avoid the need for an RVAD. If the LVAD flow rate is set too low the RV will be exposed to a high afterload and risk failure. If, on the other hand, the LVAD flow is set too high it can potentially completely empty the left ventricle with secondary geometrical distortion of the heart chambers and an increased venous return to the RV. This too increases the risk for RV failure. To find the optimal LVAD flow rate it is custom to do an extensive evaluation of central hemodynamic parameters (Cardiac Output(CO), Pulmonary Capillary Wedge Pressure (PCWP), Pulmonary Arterial Pressure (PAP), Central Venous Pressure (CVP)) and cardiac echocardiographic evaluation of RV function at different LVAD pump flow rates and MAP. The instant balance between RV filling pressure-CVP, and LV filling pressure-PCWP, is on the other hand easy to obtain. However it is not known if these measurements can be used to obtain an optimal LVAD flow rate. Furthermore all mechanically driven circulatory support devices, including LVAD, will expose the peripheral arterial circulation to a non-pulsatile blood flow.There are few previous reports on how an LVAD affects the cerebral blood flow autoregulation and microembolic load at different settings and MAP. This investigation aims to describe these cerebral effect af an LVAD using a continous Transcranial Doppler (TCD) detection of cerebral arteries.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: March 1, 2020
• Est. primary completion date: March 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• All patients receiving LVAD of the type HeartMate3® at Sahlgrenska University hospital

Exclusion Criteria:

• Perioperative need for an RVAD first 3 days postoperatively after an LVAD implantation

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure, Left-Sided
• Heart Failure, Right-Sided

Intervention

Device:
• LVAD flow velocity setting-Rounds per Minute(RPM) on HeartMate III®
Increase in LVAD RPM setting induces an actual increase in LVAD outflow to the patient.This gives the patient an increased systemic Cardiac Output(CO)

Drug:
• MAP intervention using Noradrenalin
At a fixed RPM rate for the LVAD the Mean Arterial Pressure (MAP) is increased to preset levels of 60-70-80-90 mmHG using Noradrenalin

Locations

Country	Name	City	State
Sweden	Sahlgrenska University Hospital. Department of Cardiothoracic Anaesthesia & Intensive Care	Gothenburg

Sponsors (1)

Lead Sponsor	Collaborator
Sahlgrenska University Hospital, Sweden

Country where clinical trial is conducted

Sweden, 

References & Publications (3)

Ono M, Joshi B, Brady K, Easley RB, Kibler K, Conte J, Shah A, Russell SD, Hogue CW. Cerebral blood flow autoregulation is preserved after continuous-flow left ventricular assist device implantation. J Cardiothorac Vasc Anesth. 2012 Dec;26(6):1022-8. doi: — View Citation

Uriel N, Adatya S, Malý J, Kruse E, Rodgers D, Heatley G, Herman A, Sood P, Berliner D, Bauersachs J, Haverich A, Želízko M, Schmitto JD, Netuka I. Clinical hemodynamic evaluation of patients implanted with a fully magnetically levitated left ventricular — View Citation

Uriel N, Sayer G, Addetia K, Fedson S, Kim GH, Rodgers D, Kruse E, Collins K, Adatya S, Sarswat N, Jorde UP, Juricek C, Ota T, Jeevanandam V, Burkhoff D, Lang RM. Hemodynamic Ramp Tests in Patients With Left Ventricular Assist Devices. JACC Heart Fail. 20 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes PCWP/CVP ratio at different MAP	The change in PCWP (mmHg)/CVP (mmHg) ratio at different levels of MAP as a marker for the optimal balance between LVAD flow and RV function	Change from baseline at different settings of MAP with a fixed LVAD RPM setting within 10 minutes for each level
Other	LVAD VTI at different MAP	LVAD Velocity Time Integral in centimeters(cm)	Change from baseline at different settings of MAP with a fixed LVAD RPM setting within 10 minutes for each level
Other	CO at different MAP	Cardiac Output in litres/minute	Change from baseline at different settings of MAP with a fixed LVAD RPM setting within 10 minutes for each level
Other	RVOT VTI at different MAP	RVOT Velocity Time Integral in centimeters(cm)	Change from baseline at different settings of MAP with a fixed LVAD RPM setting within 10 minutes for each level
Other	CBFV at different MAP	CBFV in cm/second	Change from baseline at different settings of MAP with a fixed LVAD RPM setting within 10 minutes for each level
Primary	Changes PCWP/CVP ratio	The change in PCWP (mmHg)/CVP (mmHg) ratio at different levels of LVAD flow as a marker for the optimal balance between LVAD flow and RV function	Change from baseline at different settings of LVAD RPM within 10 minutes for each level
Secondary	CO	Cardiac Output in litres/minute	Change from baseline at different settings of LVAD RPM within 10 minutes for each level
Secondary	LVAD Velocity Time Integral	LVAD Velocity Time Integral in centimeters(cm)	Change from baseline at different settings of LVAD RPM within 10 minutes for each level
Secondary	Right Ventricle Outflow Tract (RVOT) Velocity Time Integral (VTI)	RVOT Velocity Time Integral in centimeters(cm)	Change from baseline at different settings of LVAD RPM within 10 minutes for each level
Secondary	CBFV	CBFV in cm/second	Change from baseline at different settings of LVAD RPM within 10 minutes for each level