Central and Cerebral Circulation in Early Stages After LVAD Implantation

NCT ID: NCT03087669

Last Updated: 2017-03-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-16
• Study Completion Date: 2020-03-01

Brief 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.

Detailed 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.

Conditions

Heart Failure, Left-Sided; Heart Failure, Right-Sided

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Observation of hemodynamic parameters

LVAD flow velocity setting-Rounds Per Minute(RPM) intervention: Change of LVAD RPM while observing Central hemodynamic, echocardiographic and CBFV effects.

MAP intervention: Stepwise Change of MAP from 60-70-80 to 90 mmHg with a fixed set of LVAD RPM. After a 5 minute steady state for each level of MAP, the observations of central hemodynamics, echocardiographic measures and CBFV measurements will be repeated.

Group Type: EXPERIMENTAL

LVAD flow velocity setting-Rounds per Minute(RPM) on HeartMate III®

Intervention Type: DEVICE

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)

MAP intervention using Noradrenalin

Intervention Type: DRUG

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

Interventions

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)

Intervention Type: DEVICE

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

Intervention Type: DRUG

Other Intervention Names

RPM setting; MAP setting

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sahlgrenska University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Bjorn Reinsfelt

Head of Department of Cardiac Anesthesia. Consultant. PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sven Erik Ricksten, MD.PhD

Role: STUDY_DIRECTOR

Sahlgrenska University Hospital

Locations

Sahlgrenska University Hospital. Department of Cardiothoracic Anaesthesia & Intensive Care

Gothenburg, , Sweden

Site Status: RECRUITING

Countries

Sweden

Central Contacts

Bengt Redfors, MD.PhD

Role: CONTACT

bengt.redfors@vgregion.se

0046313427445

Bjorn Reinsfelt, MD.PhD

Role: CONTACT

bjorn.reinsfelt@gu.se

0046313428183

Facility Contacts

Bjorn Reinsfelt, PhD

Role: primary

bjorn.reinsfelt@gu.se

0046313428183

Bengt Redfors, PhD

Role: backup

bengt.redfors@vgregion.se

0046313427445

References

Uriel N, Adatya S, Maly J, Kruse E, Rodgers D, Heatley G, Herman A, Sood P, Berliner D, Bauersachs J, Haverich A, Zelizko M, Schmitto JD, Netuka I. Clinical hemodynamic evaluation of patients implanted with a fully magnetically levitated left ventricular assist device (HeartMate 3). J Heart Lung Transplant. 2017 Jan;36(1):28-35. doi: 10.1016/j.healun.2016.07.008. Epub 2016 Jul 17.

Reference Type: RESULT

PMID: 27773456 (View on PubMed)

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. 2016 Mar;4(3):208-17. doi: 10.1016/j.jchf.2015.10.001. Epub 2015 Dec 30.

Reference Type: RESULT

PMID: 26746378 (View on PubMed)

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: 10.1053/j.jvca.2012.07.014.

Reference Type: RESULT

PMID: 23122299 (View on PubMed)

Other Identifiers

ECOH 3

Identifier Type: -

Identifier Source: org_study_id