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.
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
600
Echocardiography
Herz- und Diabeteszentrum Nordrhein- Westfalen
Bad Oeynhausen, Germany
NOT_YET_RECRUITINGDeutsches Herzzentrum Berlin
Berlin, Germany
NOT_YET_RECRUITINGHeart Center of the Semmelweis University
Budapest, Hungary
NOT_YET_RECRUITINGS. Orsola Hospital, Bologna University
Bologna, Italy
RECRUITINGOspedale dei Colli
Naples, Italy
NOT_YET_RECRUITINGNational Research Cardiac Surgery Center
Astana, Kazakhstan
NOT_YET_RECRUITINGErasmus Medical Center
Rotterdam, Netherlands
RECRUITINGEge University School of Medicine
Izmir, Turkey (Türkiye)
RECRUITINGEuromacs, Eacts
Windsor, United Kingdom
ACTIVE_NOT_RECRUITINGModerate or severe RHF
RHF is defined by a triad of: 1. Clinical (right-sided congestion, with or without hypotension, or hypo-perfusion) 2. Imaging evidence (RV dilatation, new \> grade 2 tricuspid regurgitation) deterioration right ventricular function score assessed by the echocardiography core laboratory) 3. 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).
Time frame: 12 months
Severe RHF composite
The occurrence of Severe RHF composite after LVAD implantation
Time frame: 1 week, 30 days, 90 days, 180 days, 12 months
All-cause death
The occurrence of all-cause death after LVAD implantation
Time frame: 1 week, 30 days, 90 days, 180 days, 12 months
Cardiovascular death
The occurrence of cardiovascular death after LVAD implantation
Time frame: 1 week, 30 days, 90 days, 180 days, 12 months
Death or urgent transplantation
The occurrence of death or urgent transplantation after LVAD implantation
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 30 days, 90 days, 180 days, 12 months
Sepsis
The occurrence of sepsis after LVAD implantation
Time frame: 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
Time frame: 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
Time frame: 1 week, 30 days, 90 days, 180 days, 12 months
LVAD pump thrombosis
The occurrence of LVAD and driveline-related infection after LVAD implantation
Time frame: 1 week, 30 days, 90 days, 180 days, 12 months
Haemolysis
The occurrence of LVAD and driveline-related infection after LVAD implantation
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 90 days, 180 days and at 12 months
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