Design and rationale of haemodynamic guidance with CardioMEMS in patients with a left ventricular assist device: the HEMO‐VAD pilot study

Abstract

AimsWe aim to study the feasibility and clinical value of pulmonary artery pressure monitoring with the CardioMEMS™ device in order to optimize and guide treatment in patients with a HeartMate 3 left ventricular assist device (LVAD).Methods and resultsIn this single‐centre, prospective pilot study, we will include 10 consecutive patients with New York Heart Association Class IIIb or IV with Interagency Registry for Mechanically Assisted Circulatory Support Classes 2–5 scheduled for implantation of a HeartMate 3 LVAD. Prior to LVAD implantation, patients will receive a CardioMEMS sensor, for daily pulmonary pressure readings. The haemodynamic information provided by the CardioMEMS will be used to improve haemodynamic status prior to LVAD surgery and optimize the timing of LVAD implantation. Post‐LVAD implantation, the haemodynamic changes will be assessed for additive value in detecting potential complications in an earlier stage (bleeding and tamponade). During the outpatient clinic phase, we will assess whether the haemodynamic feedback can optimize pump settings, detect potential complications, and further tailor the clinical management of these patients.ConclusionsThe HEMO‐VAD study is the first prospective pilot study to explore the safety and feasibility of using CardioMEMS for optimization of LVAD therapy with additional (remote) haemodynamic information.

Left Ventricular Assist Devices 101: Shared Care for General Cardiologists and Primary Care

“…The clinical benefit of a wireless implantable hemodynamic monitoring system (CardioMEMS) in patients with LVADs is being studied in the Intellect2 and HEMO-VAD studies [44,45]. Analysis of patients from the CHAMPION Trial who subsequently received LVADs showed that PA pressures decreased dramatically post-implant in all patients, but the degree of improvement was greater in the treatment group wherein physicians used the hemodynamic information to make management decisions [46].…”

Clinical Update of the Latest Evidence for CardioMEMS Pulmonary Artery Pressure Monitoring in Patients with Chronic Heart Failure: A Promising System for Remote Heart Failure Care

“…Finally, an attempt has been made to test the feasibility of combining remote hemodynamic monitoring in patients on LVAD support in the HEMO-VAD pilot study [18]. This study focussed on hemodynamic optimization, especially with diuretics, based upon PA pressures before surgery (to truly decongest the right ventricle and kidney in order to improve post-operative outcomes) and tests the feasibility of using CardioMEMS in the outpatient clinic phase of LVAD patients for assessment of volume status, arrhythmias and other VAD related complications [18][19][20]. A larger pivotal trial is underway in the U.S. to test the clinical use of CardioMEMS in optimization of LVAD support (INTELLECT2 trial, ClinicalTrials.gov Identifier: NCT03247829).…”

Implication of Hemodynamic Assessment during Durable Left Ventricular Assist Device Support

“…Thus far, the clinical implication of ReDS in LVAD patients remains unknown. The CardioMEMS device might have the potential to be utilized in LVAD patients to monitor and adjust device parameters in response to hemodynamic status [63]. This is of course not without considering important limitations.…”