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. 2022 Apr;9(2):1118-1126.
doi: 10.1002/ehf2.13780. Epub 2022 Jan 10.

First-in-human experience of preload regulation with percutaneous transluminal caval flow regulation in heart failure with reduced ejection fraction patients

José E Herrera  1 , José A Herrera  1 , Bartolomé Finizola  1 , Eleazar García  1 , Luis E Velasco  1 , William R Torres  1 , Gabriel D'empaire  2 , José A Octavio  2 , Juan A Marqués  3 , Robert A Levine  4 , Igor F Palacios  4
Affiliations

First-in-human experience of preload regulation with percutaneous transluminal caval flow regulation in heart failure with reduced ejection fraction patients

José E Herrera et al. ESC Heart Fail. 2022 Apr.

Abstract

Aims: This study aims to investigate the acute haemodynamic effects of percutaneous transluminal flow regulation (PTCR®) with an inferior vena cava regulator balloon in heart failure patients. Preload reduction in heart failure has been achieved with high potency diuretics. However, no study has been conducted in humans to assess the effect of inferior vena cava intermittent occlusion for preload reduction.

Methods and results: Six patients were included in the study: four men (55 ± 6 years old) and two women (63 ± 4 years old). Baseline evaluations included Doppler echocardiogram, coronary angiogram, and right heart catheterization. Caval balloon was kept inflated for 30 min, and right catheterization and control echocardiogram were performed while the balloon was still inflated. The balloon was then deflated and removed. Right haemodynamic variables were evaluated before balloon insertion and with the inflated balloon. The mean right atrial pressure decreased by 42.59% (P = 0.005); systolic right ventricular pressure decreased by 30.19% (P < 0.003); mean pulmonary arterial pressure decreased by 25.33% (P < 0.043); mean pulmonary capillary wedge pressure decreased by 31.37% (P > 0.016); and cardiac output increased by 9.92% (P < 0.175).

Conclusions: The haemodynamic and echocardiographic changes obtained in our study using PTCR® suggest that this innovative approach can play a beneficial role in the heart failure treatment.

Keywords: Caval flow regulation natural phenomenon; Dynamic regulation; Dynamic stenosis; Heart failure; Inferior vena cava; Percutaneous transluminal caval flow regulation PTCR®.

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Conflict of interest statement

Igor F. Palacios declares having a relationship with the medical industry Abiomed. Juan A. Marqués declares having a relationship with the medical industry Merck Sharp & Dohme MSD.

Figures

Figure 1
Figure 1
Caval flow regulation natural phenomenon (CFRNP) or dynamic stenosis of the IVC. (A) Normal IVC in long‐axis view. (B) Abnormal IVC and dynamic restriction of the IVC flow. (C) Echo image showing IVC dynamic stenosis in expiration; the flow velocity is 1.8 m/s, which corresponds to 13.8 mmHg gradient. (D) Echo image showing IVC dynamic stenosis during inspiration; the flow velocity is 2.08 m/s, which corresponds to 17.3 mmHg gradient. (E) Important features of caval stenosis. (F) Schematic representation of the dynamic stenosis of the IVC.
Figure 2
Figure 2
Percutaneous transluminal caval flow regulation PTCR, via femoral vein for treating acute heart failure.
Figure 3
Figure 3
Haemodynamic data results.
Figure 4
Figure 4
Central figure, visual abstract.
See this image and copyright information in PMC

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