First-in-Human Experience With the ModulHeart Device for Mechanical Circulatory Support and Renal Perfusion

Georges, Gabriel; Trudeau, François; Doucet-Martineau, Jade; Rochon, Maxime; Potvin, Jeannot; Ebner, Adrián; Généreux, Philippe

doi:10.1016/j.jscai.2022.100449

Cited by 3 publications

(9 citation statements)

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“…In the first-in-human experience with ModulHeart, significant reduction in left ventricular end-diastolic pressure, pulmonary artery pressure, and central venous pressure were observed. 12 An important finding of this study is that arterial pulsatility is preserved during ModulHeart support. Loss of pulsatility with continuous flow LVADs is believed to contribute to excess bleeding risk by (1) causing angiodysplasia resulting in "leaky vessels," and (2) decreasing de novo von Willebrand factor release by vascular endothelium, thus sustaining acquired von Willebrand syndrome (secondary to supraphysiological shear stress) in LVAD patients.…”

Section: Improvement In Hemodynamic Measurementsmentioning

confidence: 69%

“…As such, changes in hemodynamic parameters may be difficult to unmask in a balance‐prone healthy physiology. In the first‐in‐human experience with ModulHeart, significant reduction in left ventricular end‐diastolic pressure, pulmonary artery pressure, and central venous pressure were observed 12 …”

Section: Discussionmentioning

confidence: 99%

“…Also, hemodynamic measurements were recorded after a relatively short stabilization period in animals compared to in humans (3 min vs. >30 min), and smaller aortic diameters in animals might have led to suboptimal pump performance due to partial restriction of pump outflow. 12 Interestingly, as pump speed was increased, pressure distal to the device increased in a near linear fashion, while proximal pressure decrement stabilized at <5 mm Hg from baseline. Substantial improvement in cardiac output may compensate for the decrease in proximal pressure at higher speeds.…”

Section: Improvement In Hemodynamic Measurementsmentioning

confidence: 93%

“…ModulHeart (Puzzle Medical Devices Inc) is a cardiorenal support device for patients with acute and chronic heart failure. The first‐in‐human experience demonstrated the safety of this approach and the beneficial impact on cardiac and renal function 12 . Unique features include the presence of multiple (3) micro‐axial endovascular pumps inserted percutaneously in series via the femoral and axillary artery and assembled in parallel within a self‐expandable anchor in the descending aorta, providing a higher degree of flow at lower speeds compared with a single pump (Figure 1).…”

Section: Introductionmentioning

confidence: 99%

“…The first-in-human experience demonstrated the safety of this approach and the beneficial impact on cardiac and renal function. 12 Unique features include the presence of multiple (3) micro-axial endovascular pumps inserted percutaneously in series via the femoral and axillary artery and assembled in parallel within a self-expandable anchor in the descending aorta, providing a higher degree of flow at lower speeds compared with a single pump (Figure 1). The main effect of the ModulHeart device is through an increase in renal blood flow and enhancement in cardiac function, mainly due to cardiac unloading.…”

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confidence: 99%

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Organ blood flow assessment with the ModulHeart cardiorenal support device

Georges,

Trudeau,

Potvin

et al. 2023

Artificial Organs

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BackgroundModulHeart (Puzzle Medical Devices Inc) is a novel percutaneous flow entrainment pump anchored in the descending aorta. The current study evaluates the hemodynamic effect of ModulHeart support and its impact on cerebral, myocardial, and renal blood flow.MethodsModulHeart was implanted in the descending aorta of four healthy calves. A ramp protocol (2000 RPM increments) was performed with the pump operating at five different speeds from 14 000 to 22 000 RPM. For each speed, pressures proximal and distal to the pump, and right heart catheterization measurements were recorded. Stable‐isotope labeled microspheres were injected in the left ventricle to evaluate organ perfusion.ResultsThermodilution cardiac output increased by 23% at 22 000 RPM. Greater pump speeds resulted in greater pump gradients, up to 10 mm Hg in mean arterial pressure at 22 000 RPM, without significant reduction of proximal perfusion pressures. Arterial pulse pressure remained stable at all speeds. ModulHeart was not associated with a reduction in cerebral or myocardial blood flow at any speed. Renal cortical and medullary blood flow increased by up to 50% and 40%, respectively.ConclusionThe ModulHeart device implanted in the descending aorta of healthy calves resulted in significant arterial pressure gradients and preserved pulse pressure. Greater pump speeds translated into greater increases in renal blood flow, with no decrease in cerebral or myocardial perfusion.

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Section: Improvement In Hemodynamic Measurementsmentioning

confidence: 69%

Section: Discussionmentioning

confidence: 99%

Section: Improvement In Hemodynamic Measurementsmentioning

confidence: 93%

Section: Introductionmentioning

confidence: 99%

mentioning

confidence: 99%

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