Serial Multiparametric Evaluation of Right Ventricular Function After Left Ventricular Assist Device Implantation (EuroEchoVAD)

A Prospective, Multicenter, Observational, Investigator Initiated Study, Aiming at Serial Multiparametric Evaluation of Right Ventricular Function to Predict Optimal Management Strategies, of Right Heart Failure After LVAD Implantation

The primary purpose of this study is to investigate the evolution of Right Ventricular (RV) function before and after left ventricular assist device (LVAD) implantation, using novel echocardiographic quantification of RV size and function in combination with comprehensive hemodynamic, laboratory and clinical parameters. The findings of the study will enhance prediction of early and late development of postoperative right-sided heart failure (RHF) and subsequent mortality and morbidity.

The secondary purpose of the study is to combine echocardiographic, hemodynamic, laboratory, and clinical data to define optimal management strategies of RHF after LVAD implantation.

Study Overview

• Status: Unknown
• Conditions: Right Heart Failure
• Intervention / Treatment: Diagnostic test: Echocardiography

Detailed Description

The study consists of 2 parts: a Pilot study and a Main Study as detailed below.

The purpose of the Pilot study is to evaluate the feasibility of RV quantification using two-, three-dimensional and Multiplane echocardiography.

About 100 subjects undergoing LVAD implantation in the European Registry for Patients with Mechanical Circulatory Support (EUROMACS) Registry are included in the Pilot study. These 100 patients will undergo routinely scheduled echocardiography before, within 1 week, 3 months and 1 year after LVAD implantation. Echocardiography will be performed using ultrasound machines that are capable of acquisition of two-, three-dimensional and Multiplane Echocardiography of the right ventricle.

Echocardiographic analysis will include three-dimensional quantification of the RV size and function as well as RV strain analysis in the Multiplane format as described in the Appendix Echocardiography Procedure Manual.

The Echocardiographic analyses of the first 50 patients, included in selected sites, will be used to further specify the protocol for image acquisition and analysis to be used in the Main Study. Furthermore, all sites will first enter 2 patients in the Pilot Study before they can participate in the Main Study. The echocardiographic results of these 2 patients will be assessed by the core lab for quality.

The purpose of the Main Study is to assess the evolution of RV function before and after LVAD implantation utilizing the acquisition and analysis protocol developed in the Pilot Study.

500 patients will undergo routinely scheduled echocardiographic imaging before LVAD implantation, and at 1 week, 1 month, 3 months, 6 months and 1 year thereafter. Echocardiography will be performed using the detailed protocol developed in the Pilot Study. All Echocardiographic images will be submitted to an independent Core Laboratory for analysis.

The evolution of RV function will be documented with standardised two-, three-dimensional and Multiplane Echocardiography of the right ventricle. The echocardiographic parameters include: RV strain and strain rate, RV Fractional Area Change, RV longitudinal function, RV volumes, RV ejection fraction, tricuspid regurgitation severity, estimated pulmonary artery pressures, pulmonary artery resistance, pulmonary artery compliance, RV stroke work index, right atrial size, and RV - pulmonary coupling.

Invasive hemodynamic data will be collected in the perioperative period. These RV parameters will be linked to the occurrence of clinical signs, hemodynamic and laboratory evidence of RHF.

• Study Type: Observational
• Enrollment (Anticipated): 600

Contacts and Locations

• Study Contact: Name: Osama SOLIMAN, MD, PhD; Phone Number: +31643158470; Email: osoliman@eurohf.org
• Study Contact Backup: Name: Kadir Caliskan, MD, PhD; Phone Number: +31681268158; Email: k.caliskan@erasmusmc.nl

Study Locations

• Germany
  • Bad Oeynhausen, Germany
    • Not yet recruiting
    • Herz- und Diabeteszentrum Nordrhein- Westfalen
    • Contact: Lech Paluszkiewicz, MD, PhD
    • Principal Investigator: Lech Paluszkiewicz, MD, PhD
  • Berlin, Germany
    • Not yet recruiting
    • Deutsches Herzzentrum Berlin
    • Contact: Felix Schönrath, MD, PhD
    • Principal Investigator: Felix Schönrath, MD, PhD
• Hungary
  • Budapest, Hungary
    • Not yet recruiting
    • Heart Center of the Semmelweis University
    • Contact: Béla Merkely, MD, PhD
    • Principal Investigator: Bela Merkely, MD, PhD
• Italy
  • Bologna, Italy
    • Recruiting
    • S. Orsola Hospital, Bologna University
    • Contact: Antonio Loforte, MD, PHD
    • Principal Investigator: Antonio Loforte
  • Naples, Italy
    • Not yet recruiting
    • Ospedale Dei Colli
    • Contact: Cristiano Amarelli
    • Principal Investigator: Cristiano Amarelli, MD, PhD
• Kazakhstan
  • Astana, Kazakhstan
    • Not yet recruiting
    • National Research Cardiac Surgery Center
    • Contact: Makhabbat Bekbossynova, MD, PhD
    • Principal Investigator: Makhabbat Bekbossynova, MD, PhD
• Netherlands
  • Rotterdam, Netherlands
    • Recruiting
    • Erasmus Medical Center
    • Contact: Kadir Caliskan, MD, PhD
    • Principal Investigator: Kadir Caliskan, MD, PhD
• Turkey
  • İzmir, Turkey
    • Recruiting
    • Ege University School of Medicine
    • Contact: Sanem Nalbantgil, MD, PhD
    • Principal Investigator: Sanem Nalbantgil, MD, PhD
    • Principal Investigator: Mustafa Özbaran, MD, PhD
• United Kingdom
  • Windsor, United Kingdom
    • Active, not recruiting
    • Euromacs, Eacts

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Consecutive patients who underwent LVAD implantation using main stream devices

Description

Inclusion Criteria:

Subjects to be included in the study must meet the following inclusion criteria:

1. Consecutive patients accepted for elective LVAD implantation in the context of routine care
2. >17 years of age
3. Written informed consent (IC), either by the patient or by legal representatives
4. Treated with mainstream devices

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

LVAD recipients; Consecutive patients accepted for elective LVAD implantation in the context of routine care, will undergo routinely scheduled echocardiography before, within 1 week, 1 month, 3 months and 1 year after LVAD implantation. Echocardiography will be performed using ultrasound machines that are capable of acquisition of two-, three-dimensional and Multiplane Echocardiography of the right ventricle. Invasive hemodynamic data will be collected in the perioperative period.

Diagnostic test: Echocardiography; Echocardiography

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Moderate or severe RHF	RHF is defined by a triad of: Clinical (right-sided congestion, with or without hypotension, or hypo-perfusion); Imaging evidence (RV dilatation, new > grade 2 tricuspid regurgitation) deterioration right ventricular function score assessed by the echocardiography core laboratory); Hemodynamic evidence (discordant elevated central venous pressure (CVP) or right atrial pressure (RAP) >16 mmHg, despite normal or steady pulmonary capillary wedge pressure (PCWP), or right atrial (RA) to PCWP ratio >0.54).	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severe RHF composite	The occurrence of Severe RHF composite after LVAD implantation	1 week, 30 days, 90 days, 180 days, 12 months
All-cause death	The occurrence of all-cause death after LVAD implantation	1 week, 30 days, 90 days, 180 days, 12 months
Cardiovascular death	The occurrence of cardiovascular death after LVAD implantation	1 week, 30 days, 90 days, 180 days, 12 months
Death or urgent transplantation	The occurrence of death or urgent transplantation after LVAD implantation	1 week, 30 days, 90 days, 180 days, 12 months
Length of post-operative Intensive Care Unit (ICU) stay	The length of post-operative ICU stay in days after LVAD implantation	30 days, 90 days, 180 days, 12 months
Length of post-operative hospital stay	The length of post-operative hospital stay in days after LVAD implantation	30 days, 90 days, 180 days, 12 months
Readmissions for heart failure or RHF	The occurrence of hospital readmissions for heart failure or RHF after LVAD implantation	30 days, 90 days, 180 days, 12 months
Sepsis	The occurrence of sepsis after LVAD implantation	1 week, 30 days, 90 days, 180 days, 12 months
LVAD and driveline-related infection	The occurrence of LVAD and driveline-related infection after LVAD implantation	1 week, 30 days, 90 days, 180 days, 12 months
Early and late bleeding complications	The occurrence of LVAD and driveline-related infection after LVAD implantation	1 week, 30 days, 90 days, 180 days, 12 months
LVAD pump thrombosis	The occurrence of LVAD and driveline-related infection after LVAD implantation	1 week, 30 days, 90 days, 180 days, 12 months
Haemolysis	The occurrence of LVAD and driveline-related infection after LVAD implantation	1 week, 30 days, 90 days, 180 days, 12 months
Arterial thromboembolic events, including stroke	The occurrence of LVAD and driveline-related infection after LVAD implantation	1 week, 30 days, 90 days, 180 days, 12 months
Venous thromboembolic events, including deep venous thrombosis (DVT) and pulmonary embolism (PE)	The occurrence of LVAD and driveline-related infection after LVAD implantation	1 week, 30 days, 90 days, 180 days, 12 months
Ventricular arrhythmias, either sustained symptomatic or with appropriate Implantable Cardioverter Defibrillator (ICD) therapy	The occurrence of LVAD and driveline-related infection after LVAD implantation	1 week, 30 days, 90 days, 180 days, 12 months
Atrial arrhythmias - documented atrial flutter or fibrillation	The occurrence of LVAD and driveline-related infection after LVAD implantation	1 week, 30 days, 90 days, 180 days, 12 months
Acute Kidney Injury (AKI) according to Kidney Disease Outcomes Quality Initiative (KDIGO) and RIFFLE criteria	The occurrence of LVAD and driveline-related infection after LVAD implantation	1 week, 30 days, 90 days, 180 days, 12 months
Chronic kidney disease (CKD) according to KDOQI criteria	The occurrence of Chronic kidney disease (CKD) according to KDOQI criteria after LVAD implantation	1 week, 30 days, 90 days, 180 days, 12 months
Six Minute walk distance in meters	Assessment of Six Minute walk distance in meters before and after LVAD implantation	90 days and 12 months
Quality of life (QoL) scores	QoL by multiple assessments before and at 90 days, 180 days and at 12 months after LVAD implantation at	90 days, 180 days and at 12 months

Collaborators and Investigators

• Sponsor: Erasmus Medical Center
• Collaborators: The European Association for Cardio-Thoracic Surgery
• Investigators: Principal Investigator: Osama SOLIMAN, MD, PhD, Euro Heart Foundation; Principal Investigator: Kadir Caliskan, MD, PhD, Erasmus MC Rotterdam

Publications and helpful links

General Publications

• Soliman OII, Akin S, Muslem R, Boersma E, Manintveld OC, Krabatsch T, Gummert JF, de By TMMH, Bogers AJJC, Zijlstra F, Mohacsi P, Caliskan K; EUROMACS Investigators. Derivation and Validation of a Novel Right-Sided Heart Failure Model After Implantation of Continuous Flow Left Ventricular Assist Devices: The EUROMACS (European Registry for Patients with Mechanical Circulatory Support) Right-Sided Heart Failure Risk Score. Circulation. 2018 Feb 27;137(9):891-906. doi: 10.1161/CIRCULATIONAHA.117.030543. Epub 2017 Aug 27.

Study record dates

Study Major Dates

• Study Start (Actual): June 24, 2018
• Primary Completion (Anticipated): February 1, 2021
• Study Completion (Anticipated): July 1, 2021

Study Registration Dates

• First Submitted: May 27, 2018
• First Submitted That Met QC Criteria: June 8, 2018
• First Posted (Actual): June 12, 2018

Study Record Updates

• Last Update Posted (Actual): October 11, 2019
• Last Update Submitted That Met QC Criteria: October 10, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: Mortality; Acute Kidney Injury; Right Heart Failure; Ventricular Assist Device; ICU Stay
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: WT/aj/MEC-2018-1162

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No