Hemodynamical Evaluation of a New Surgically Implanted Pulsatile Right Ventricular Assist Device Driven by a Conventional Intra-Aortic Balloon Pump Console.

Severe right heart failure, often overlooked and challenging to manage, has prompted a growing interest in innovative approaches to provide functional support. This study uses experimentation in large porcine models to introduce a novel prototype of a pulsatile mechanical circulatory support device and document its effects when deployed as a right ventricular assist device (RVAD). The pulsatile ventricular assist platform (pVAP), featuring a membrane pump driven by an intra-aortic balloon pump console, actively generates pulsatile flow to propel right ventricular blood into the pulmonary artery. This novel prototype demonstrates promising potential in addressing the challenges of right heart failure management. After preliminary in vitro assessments, the pVAP was tested on seven porcine models in a healthy state and after the induction of right ventricular failure. During the procedure, a set of standard (ie, standard-of-care) hemodynamic measurements was obtained. Additionally, invasive pressure-volume loop analysis was employed to examine left ventricular hemodynamics. Results indicated that activation of the pVAP during right ventricular failure significantly improved systemic hemodynamics and enhanced left ventricular function. This study sheds light on the potential of the pVAP in managing right heart failure.

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.

Case Report First-in-Man Method Description: Left Ventricular Unloading With iVAC2L During Veno-Arterial Extracorporeal Membrane Oxygenation: From Veno-Arterial Extracorporeal Membrane Oxygenation to ECMELLA to EC-iVAC®.

Veno-arterial extracorporeal membrane oxygenation (V-A ECMO) is increasingly used in bi-ventricular failure with cardiogenic shock to maintain systemic perfusion. Nonetheless, it tends to increase left ventricular (LV) afterload and myocardial oxygen demand. In order to mitigate these negative effects on the myocardium, an Impella CP® (3.5 L/min Cardiac Output) can be used in conjunction with V-A ECMO (ECMELLA approach). We implemented this strategy in a patient with severe acute myocarditis complicated by cardiogenic shock. Due to a hemolysis crisis, Impella CP® had to be substituted with PulseCath iVAC2L®, which applies pulsatile flow to unload the LV. A subsequent improvement in LV systolic function was noted, with increased LV ejection fraction (LVEF), LV end-diastolic diameter (LVEDD) reduction, and a reduction in plasma free hemoglobin. This case documents the efficacy of iVAC2L in replacing Impella CP as a LV vent during V-A ECMO, with less hemolysis.

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.

Determination of cardiac output from pulse pressure contour during intra-aortic balloon pumping in patients with low ejection fraction.

Evaluation of a new Windkessel model based pulse contour method (WKflow) to calculate stroke volume in patients undergoing intra-aortic balloon pumping (IABP). Preload changes were induced by vena cava occlusions (VCO) in twelve patients undergoing cardiac surgery to vary stroke volume (SV), which was measured by left ventricular conductance volume method (SVlv) and WKflow (SVwf). Twelve VCO series were carried out during IABP assist at a 1:2 ratio and seven VCO series were performed with IABP switched off. Additionally, SVwf was evaluated during nine episodes of severe arrhythmia. VCO's produced marked changes in SV over 10-20 beats. 198 paired data sets of SVlv and SVwf were obtained. Bland-Altman analysis for the difference between SVlv and SVwf during IABP in 1:2 mode showed a bias (accuracy) of 1.04 ± 3.99 ml, precision 10.9% and limits of agreement (LOA) of - 6.94 to 9.02 ml. Without IABP bias was 0.48 ± 4.36 ml, precision 11.6% and LOA of - 8.24 to 9.20 ml. After one thermodilution calibration of SVwf per patient, during IABP the accuracy improved to 0.14 ± 3.07 ml, precision to 8.3% and LOA to - 6.00 to + 6.28 ml. Without IABP the accuracy improved to 0.01 ± 2.71 ml, precision to 7.5% and LOA to - 5.41 to + 5.43 ml. Changes in SVlv and SVwf were directionally concordant in response to VCO's and during severe arrhythmia. (R2 = 0.868). The SVwf and SVlv methods are interchangeable with respect to measuring absolute stroke volume as well as tracking changes in stroke volume. The precision of the non-calibrated WKflow method is about 10% which improved to 7.5% after one calibration per patient.

Primary intra-aortic balloon support versus inotropes for decompensated heart failure and low output: a randomised trial.

AIMS: The haemodynamic effects of primary implantation of an intra-aortic balloon pump (IABP) versus inotropes in decompensated heart failure and low output (DHF-LO), but without an acute coronary syndrome, have not been investigated. We therefore aimed to investigate the effect of primary IABP implantation as compared to inotropes on haemodynamics in DHF-LO with no acute ischaemia. METHODS AND RESULTS: Patients (n=32) with DHF-LO despite IV diuretics were randomised to primary 50 mL IABP or inotropes (INO: enoximone or dobutamine). The primary endpoint was the improvement of organ perfusion assessed by ∆ mixed-venous oxygen saturation (SvO2) at 3 hours; secondary endpoints included ∆ cardiac power output (CPO), NT-proBNP proportional change, cumulative fluid balance and ∆ dyspnoea severity score, all at 48 hours. Data are presented as median (IQR). Patients were 60 (48-69) years old and 72% were male. Baseline SvO2 was 44 (39-53)%. ∆SvO2 was higher in the IABP group (+17 [+9; +24] vs. +5 [+2; +9]%, p<0.05). IABP patients had a higher ∆CPO, a greater relative reduction in NT-proBNP, a more negative cumulative fluid balance, and a greater reduction in dyspnoea severity score. There were no IABP-related serious adverse events (SAEs). Thirty-day mortality was 23% (IABP) vs. 44% (INO). CONCLUSIONS: Primary circulatory support by IABP showed a significant increase in improved organ perfusion assessed by SvO2.

New-generation mechanical circulatory support during high-risk PCI: a cross-sectional analysis.

AIMS: The aim of the study was to establish the value of new-generation mechanical circulatory support (MCS) devices such as HeartMate PHP, Impella CP and PulseCath iVAC2. METHODS AND RESULTS: We retrospectively analysed all consecutive elective high-risk PCI procedures performed in the Erasmus Medical Center (2011-2018) in order to compare MCS protected and unprotected patients. The primary endpoint was a composite of procedure-related adverse events including death (<24 hours), cardiac arrest, need for vasopressors, rescue MCS, endotracheal intubation and limb ischaemia with need for surgery. Secondary endpoints included 30-day survival. A total of 198 elective high-risk PCI patients were included (69 [35%] MCS protected, 129 [65%] MCS unprotected). When compared with unprotected patients, MCS protected patients had a significantly worse left ventricular ejection fraction (LVEF) (25±10 vs 33±8%, p<0.01) and higher SYNTAX I score (33±11 vs 24±8, p<0.01). The primary endpoint occurred in 26 (20%) of the unprotected patients and in 6 (9%) of the MCS protected patients (OR 0.38, 95% CI: 0.15-0.97, p=0.04). Patients under 75 years of age, with a SYNTAX I score above 32 and with an LVEF below 30% showed most potential benefit from MCS. Survival during the first 24 hours after the procedure and at 30 days was significantly higher in MCS protected patients (100% vs 95%, p=0.04 at 24 hours, and 98% vs 87%, OR 10.32, 95% CI: 1.34-79.31, p=0.006 at 30 days). CONCLUSIONS: In a consecutive real-world cohort of high-risk PCI patients, protection with new-generation MCS resulted in better procedural outcomes despite worse EF and more complex coronary artery disease at baseline. Larger prospective studies are needed to confirm these findings.

Pressure-volume analysis in athyroid patients off and on thyroxine supplementation: a pilot study.

Thyroid hormone importantly affects the cardiovascular system. However, evaluation of stroke volume (SV) and its determinants is confounded by variations in volume status that occur along different thyroid states. This study applied the pressure-volume (PV) framework to obtain relatively load-independent estimates of cardiac function in hypothyroidism as compared to euthyroidism. Ten athyroid patients were assessed echocardiographically after 4 weeks in deep hypothyroid state, and again after supplementation with oral Levothyroxine (LT4) for 3 months. Thyroid hormone levels were assessed and noninvasive pressure-volume (PV) analysis based on dedicated repeated echocardiograms was performed. Changes were assessed using paired tests. Results are presented as medians and interquartile ranges. Hypothyroidism was associated with reduced stroke volume (SV: 67.6 ± 17 vs. 75.7 ± 20.6 mL, P = 0.024), preload (end-diastolic volume, EDV: 122.6 ± 32.5 vs. 135.7 ± 33.6 mL, P = 0.004), and contractility (end-systolic elastance, Ees : 1.7 ± 0.33 vs. 2.58 ± 1.33 mmHg/mL, P = 0.01). Afterload was constant (effective arterial elastance, Ea : 1.66 ± 0.32 vs. 1.79 ± 0.52 mmHg/mL, P = 0.43) and the total energy spent was lower (PVA∙HR: 86.7 ± 28 vs. 110.9 ± 32.1 J, P = 0.04). Hemodynamic manifestations of frank hypothyroidism in humans are characterized by reduced preload and contractility, and unchanged total afterload. LT4 therapy increased work efficiency and heart rate, but not the net energy expenditure. Noninvasive PV analysis may be useful to follow-up different thyroid states.

Interlaminar epidural corticosteroid injection in the treatment of lumbosciatic pain: a retrospective analysis

Lumbosciatica is a common condition which is associated with significant pain and disability. The aim of the present study was to examine the efficacy of interlaminar epidural corticosteroid infiltration in the treatment of lumbosciatic pain. We evaluated retrospectively sixty patients with lumbosciatic pain that a sequential interlaminar epidural administration of 40 mg methylprednisolone in 7 mL bupivacaine 0.25 percent was administered. Each patient was interviewed and asked about the pain according to visual analogue scale (VAS) and the level of disability according to World Health Organization previously of the epidural corticosteroid infiltration and, 1 and, 6 months after starting therapy. Independently of the initial VAS value, all patients decreased their pain score after one and six months of follow-up (p<0.05). However, only the patients with a low grade of disability showed an improvement after the treatment (p<0.05). No side effects were reported after epidural corticosteroid injections. In conclusion, interlaminar epidural corticosteroid injection in association with local anesthetic may be useful, at least for six months, as additional therapy of the conservative management of lumbosciatic pain.

A lombociatalgia é condição clínica associada à dor intensa e alterações funcionais. O objetivo do presente estudo foi examinar a eficácia da infiltração de corticóide pela via epidural interlaminar no tratamento da dor da lombociatalgia. Foram avaliados, retrospectivamente, sessenta pacientes com lombociatalgia que foram submetidos à administração epidural interlaminar, em sequência, de 40 mg de metilprednisolona e 7 mL de bupivacaína a 0,25 por cento. Os pacientes foram avaliados em relação à dor de acordo com a escala visual analógica (EVA) e o grau de comprometimento funcional de acordo com a Organização Mundial de Saúde antes e, uma e, seis meses após o início do tratamento. Independentemente do valor inicial da EVA, todos os pacientes diminuíram o escore de dor após um e, seis meses de acompanhamento (p<0.05). Entretanto, apenas os pacientes com baixo grau de comprometimento funcional apresentaram melhora após o tratamento (p<0.05). Não foram observados efeitos colaterais após as injeções de corticóide epidural. Concluindo, a injeção epidural interlaminar de corticóide em associação com anestésico local pode ser benéfico, por pelo menos seis meses, como terapia coadjuvante no tratamento conservador da dor da lombociatalgia.

Interlaminar epidural corticosteroid injection in the treatment of lumbosciatic pain: a retrospective analysis.

Lumbosciatica is a common condition which is associated with significant pain and disability. The aim of the present study was to examine the efficacy of interlaminar epidural corticosteroid infiltration in the treatment of lumbosciatic pain. We evaluated retrospectively sixty patients with lumbosciatic pain that a sequential interlaminar epidural administration of 40 mg methylprednisolone in 7 mL bupivacaine 0.25% was administered. Each patient was interviewed and asked about the pain according to visual analogue scale (VAS) and the level of disability according to World Health Organization previously of the epidural corticosteroid infiltration and, 1 and, 6 months after starting therapy. Independently of the initial VAS value, all patients decreased their pain score after one and six months of follow-up (p<0.05). However, only the patients with a low grade of disability showed an improvement after the treatment (p<0.05). No side effects were reported after epidural corticosteroid injections. In conclusion, interlaminar epidural corticosteroid injection in association with local anesthetic may be useful, at least for six months, as additional therapy of the conservative management of lumbosciatic pain.

Determinaçäo de açúcares em mel floral e mel de melato de algumas regiöes de Minas Gerais e de Santa Catarina / Sugar determination in floral honey and honey dew from regions of Minas Gerais and Santa Catarina

O mel de melato difere do mel floral em relaçäo à sua composiçäo em açúcares. Afim de verificar estas diferenças, foram analisadas 14 amostras de mel floral e 11 amostras de mel de melato e determinados os teores de frutose, glicose, sacarose, maltose, melezitose, erlose e rafinose por cromatografia líquida de alta eficiência com dectetor de índice de refraçäo. Foram testadas diferentes fases móveis para separar melezitose de erlose que säo trissacarideos presentes no mel. O mel de melato apresentou teor de glicose menor que o mel floral, o que foi estatisticamente confirmado pelo teste U de Mann-Whitney. A erlose estava presente em todas as amostras. Näo foi detectada meletizose nas amostras de mel floral. (AU)

Honeydew honey differs of floral honey in sugar aspecto In order to check that, eleven honeydew honey and fourteen floral honey were analysed for frutose, glucose, sucrose, melezitose, erlose and rafinose by high performance liquid chromatography with refractive index detector. Differents mobille phases were tested to separate melezitose from erlose, both are trissacharides commonly found in honey. Honeydew honey presented less glucose contente than honey and erlose was presente in ali oneydew honey. Melezítose was not detected in t10- ral honey samples. (AU)