Effect of Next Generation Pulsatile Mechanical Circulatory Support on Cardiac Mechanics: The PULSE Trial.

OBJECTIVES: To describe hemodynamic effects of iVAC2L mechanical circulatory support (MCS). BACKGROUND: MCS is increasingly used in the context of high-risk percutaneous coronary intervention (PCI). The effect of the pulsatile iVAC2L MCS on left ventricular loading conditions and myocardial oxygen consumption (MVO2) is unknown. METHODS: This prospective single-arm two-center study included 29 patients who underwent high-risk PCI with iVAC2L MCS using simultaneous invasive pulmonary pressure monitoring and left ventricular pressure-volume analysis. Hemodynamic recordings were performed during steady state conditions with MCS off and on before and after PCI. Pressure-volume variations were analyzed to denote responders and non-responders. RESULTS: The mean age was 74 (IQR: 70-81) years and the mean SYNTAX score was 31 ± 8.3. Left ventricular unloading with iVAC2L MCS was demonstrated in 22 out of 27 patients with complete PV studies. Patients with moderate or severe mitral regurgitation or presenting with acute coronary syndrome (ACS) had higher filling pressures and volumes and were most responsive to iVAC2L unloading (9/10 patients with moderate or severe MR and 11/11 patients with ACS). Pulsatile MCS activation reduced MAP (-4%), SBP (-9%), ESP (-11%), ESV (-15%) and EDV (-4%) among responders but not among non-responders. Responders experienced significant reductions in afterload (Ea: -19%) with increases in stroke volume (+11%) and cardiac output (+11%). CONCLUSIONS: Pulsatile iVAC2L MCS in patients with advanced coronary artery disease at high to prohibitive operative risk resulted in LV unloading and reduced myocardial oxygen consumption particularly in patients with ACS or significant MR with higher filling pressures at baseline. CLINICAL TRIAL REGISTRATION: NCT03200990.

Invasive Right Ventricular Pressure-Volume Analysis: Basic Principles, Clinical Applications, and Practical Recommendations.

Right ventricular pressure-volume (PV) analysis characterizes ventricular systolic and diastolic properties independent of loading conditions like volume status and afterload. While long-considered the gold-standard method for quantifying myocardial chamber performance, it was traditionally only performed in highly specialized research settings. With recent advances in catheter technology and more sophisticated approaches to analyze PV data, it is now more commonly used in a variety of clinical and research settings. Herein, we review the basic techniques for PV loop measurement, analysis, and interpretation with the aim of providing readers with a deeper understanding of the strengths and limitations of PV analysis. In the second half of the review, we detail key scenarios in which right ventricular PV analysis has influenced our understanding of clinically relevant topics and where the technique can be applied to resolve additional areas of uncertainty. All told, PV analysis has an important role in advancing our understanding of right ventricular physiology and its contribution to cardiovascular function in health and disease.

Invasive Real Time Biventricular Pressure-Volume Loops to Monitor Dynamic Changes in Cardiac Mechanoenergetics During Structural Heart Interventions: Design and Rationale of a Prospective Single-Center Study.

Background: Transcatheter valvular interventions affect cardiac and hemodynamic physiology by changing ventricular (un-)loading and metabolic demand as reflected by cardiac mechanoenergetics. Real-time quantifications of these changes are scarce. Pressure-volume loop (PVL) monitoring appraises both load-dependent and load-independent compounds of cardiac physiology including myocardial work, ventricular unloading, and ventricular-vascular interactions. The primary objective is to describe changes in physiology induced by transcatheter valvular interventions using periprocedural invasive biventricular PVL monitoring. The study hypothesizes transcatheter valve interventions modify cardiac mechanoenergetics that translate into improved functional status at 1-month and 1-year follow-up. Methods: In this single-center prospective study, invasive PVL analysis is performed in patients undergoing transcatheter aortic valve replacement or tricuspid or mitral transcatheter edge-to-edge repair. Clinical follow-up is per standard of care at 1 and 12 months. This study aims to include 75 transcatheter aortic valve replacement patients and 41 patients in both transcatheter edge-to-edge repair cohorts. Results: The primary outcome is the periprocedural change in stroke work, potential energy, and pressure-volume area (mmHg mL-1). The secondary outcomes comprise changes in a myriad of parameters obtained by PVL measurements, including ventricular volumes and pressures and the end-systolic elastance-effective arterial elastance ratio as a reflection of ventricular-vascular coupling. A secondary endpoint associates these periprocedural changes in cardiac mechanoenergetics with functional status at 1 month and 1 year. Conclusions: This prospective study aims to elucidate the fundamental changes in cardiac and hemodynamic physiology during contemporary transcatheter valvular interventions.

PulseCath iVAC2L: next-generation pulsatile mechanical circulatory support.

Contemporary state of the art percutaneous coronary intervention techniques offer treatment strategies and solutions to an increasing number of patients with heart failure and complex coronary artery disease. Percutaneous mechanical circulatory support is intended to alleviate the mechanical and energetic workload imposed to a failing ventricle by reducing left ventricle pressures and volumes and potentially also increasing coronary blood flow. The PulseCath iVAC2L is a transaortic left ventricular assist device that applies a pneumatic driving system to produce pulsatile forward flow. Herein, the essential aspects regarding iVAC2L are discussed with focus on its mechanisms of action and the available clinical experience.

Pressure-Volume Loop Analysis in Percutaneous Coronary Intervention-Induced Shock.

High-risk percutaneous coronary intervention may lead to undesirable clinical scenarios such as cardiogenic shock. We describe the hemodynamic changes using pressure-volume loop analyses in percutaneous coronary intervention-induced shock. (PULsecath mechanicaL Support Evaluation [PULSE]; NCT03200990) (Level of Difficulty: Intermediate.).

Invasive left ventricle pressure-volume analysis: overview and practical clinical implications.

Ventricular pressure-volume (PV) analysis is the reference method for the study of cardiac mechanics. Advances in calibration algorithms and measuring techniques brought new perspectives for its application in different research and clinical settings. Simultaneous PV measurement in the heart chambers offers unique insights into mechanical cardiac efficiency. Beat to beat invasive PV monitoring can be instrumental in the understanding and management of heart failure, valvular heart disease, and mechanical cardiac support. This review focuses on intra cardiac left ventricular PV analysis principles, interpretation of signals, and potential clinical applications.