development-an-ex-vivo-mitral-valve-evaluation-model-using-pulsatile

Development of an <em>Ex Vivo</em> Mitral Valve Evaluation Model Using a Pulsatile Flow Simulator

Surgical mitral valve repair remains a challenging procedure. Although several repair techniques have been defined, data comparing their hemodynamic ...

Istanbul Bilgi University

End-stage Fontan patients with single-ventricle (SV) circulation are often bridged-to-heart transplantation via mechanical circulatory support (MCS). Donor shortage and complexity of the SV physiology demand innovative MCS. In this paper, an out-of-the-box circulation concept, in which the left and right ventricles are switched with each other is introduced as a novel bi-ventricle MCS configuration for the "failing" Fontan patients. In the proposed configuration, the systemic circulation is maintained through a conventional mechanical ventricle assist device (VAD) while the venous circulation is delegated to the native SV. This approach spares the SV and puts it to a new use at the right-side providing the most-needed venous flow pulsatility to the failed Fontan circulation. To analyze its feasibility and performance, eight SV failure modes have been studied via an established multi-compartmental lumped parameter cardiovascular model (LPM). Here the LPM model is experimentally validated against the corresponding pulsatile mock-up flow loop measurements of a representative 15-year-old Fontan patient employing a clinically-approved VAD (Medtronic-HeartWare). The proposed surgical configuration maintained the healthy cardiac index (3-3.5 l/min/m) and the normal mean systemic arterial pressure levels. For a failed SV with low ejection fraction (EF = 26%), representing a typical systemic Fontan failure, the proposed configuration enabled a ~ 28 mmHg amplitude in the venous/pulmonary waveforms and a 2 mmHg decrease in the central venous pressure (CVP) together with acceptable mean pulmonary artery pressures (17.5 mmHg). The pulmonary vascular resistance (PVR)-SV failure case provided a ~ 5 mmHg drop in the CVP, with venous/pulmonary pulsatility reaching to ~ 22 mmHg. For the high PVR failure case with a healthy SV (EF = 44%) pulmonary hypertension is likely to occur as expected. While this condition is routinely encountered during the heart transplantation and managed through pulmonary vasodilators a need for precise functional assessment of the spared failed-ventricle is recommended if utilized in the PVR failure mode. Comprehensive in vitro and in silico results encourage this novel concept as a low-cost, more physiological alternative to the conventional bi-ventricle MCS pending animal experiments.

Switching the Left and the Right Hearts: A Novel Bi-ventricle Mechanical Support Strategy with Spared Native Single-Ventricle.

Percutaneous pulmonary valve implantation (PPVI) has emerged as a less invasive alternative for treating severe pulmonary regurgitation after tetralogy of Fallot (TOF) repair in patients with a native right ventricular outflow tract (RVOT). However, the success of PPVI depends on precise patient-specific valve sizing, the avoidance of oversizing complications, and optimal valve performance. In recent years, innovative adaptations of commercially available cardiovascular mock loops have been used to test conduits in the pulmonary position. These models are instrumental in facilitating accurate pulmonic valve sizing, mitigating the risk of oversizing, and providing insight into the valve performance before implantation. This study explored the utilization of custom-modified mock loops to implant patient-specific 3D-printed pulmonary artery geometries, thereby advancing PPVI planning and execution.

Optimizing percutaneous pulmonary valve implantation with patient-specific 3D-printed pulmonary artery models and hemodynamic assessment.

Fontan Failure (FF) is a common problem for single-ventricle patients as they reach adulthood. Although several mechanisms may cause FF, an optimized blood flow stream through the surgical conduits is essential to avoid excessive energy loss (EL). Recent clinical studies showed EL is related to the quality of life, exercise capacity, and hepatic function since the single-ventricle feeds pulmonary and systemic circulation serially. 4D flow MRI effectively estimates EL in Fontan circulation and allows clinicians to compare the effectiveness of the treatment strategy concerning pre-intervention. Here, we present 26-year-old women with FF who had normal cardiac catheterization findings and were treated according to high EL definitions that are measured through 4D flow MRI.

Evaluation of the total hydrodynamic energy loss using 4D flow MRI in a case with Fontan failure.

Tetralogy of Fallot often requires transannular patch repair, leading to pulmonary insufficiency. Percutaneous pulmonary valve implantation (PPVI) with self-expandable valves offers a promising alternative, especially for enlarged right ventricular Queryoutflow tracts (RVOT). Five RVOT types identified in patients with Tetralogy of Fallot reflect anatomical variations due to disease and prior surgeries. This study assesses the Pulsta THV® valve's in vitro hemodynamic performance across these RVOT morphologies using 3D-printed models. Five RVOT morphologies were recreated as 3D models from patient-specific imaging data. The Pulsta THV® valves, available in 28, 30, and 32 mm sizes, were evaluated using the ViVitro Pulse Duplicator System at three cardiac outputs (2, 3.5, and 5 L/min). Hemodynamic performance was assessed by measuring regurgitation rates and pressure gradients in the left and right pulmonary arteries. The Pulsta THV® performed optimally in RVOT Types 1 and 2, demonstrating lower regurgitation rates and pressure gradients, particularly with larger valve sizes. Conversely, RVOT Types 3 and 5 showed increased pressure gradients and hemodynamic variability, indicating less favorable outcomes. The results highlighted the critical role of precise anatomical compatibility, with larger valve sizes proving more effective in enlarged RVOT geometry. Valve sizes tailored to specific RVOT morphologies can enhance PPVI outcomes. Types 1 and 2 are ideal for PPVI, while Types 3 and 5 present challenges due to hemodynamic variability. This study supports 3D modeling and in vitro testing for pre-procedural planning to reduce complications, with future research exploring dynamic imaging and materials mimicking tissue properties.

3D Modeling of Self-Expandable Valves for PPVI in Distinct RVOT Morphologies.

Small-sized right ventricle to pulmonary artery conduits are hindered by calcification, degeneration, or infective endocarditis and face limited availability. Valved conduits of expanded polytetrafluoroethylene leaflets offer a promising path toward enhanced longevity and performance. This in-vitro study introduces innovative expanded polytetrafluoroethylene valve designs for small-sized conduits.Three bicuspid and three tricuspid expanded polytetrafluoroethylene leaflets designed for size 12 mm were tested using an in-vitro pediatric right-heart mock-up loop and compared with our baseline leaflet design. Polyvinylchloride was used to create a transparent tube for visual access. Regurgitation rates, pressure gradients, effective orifice area under 0.5-3 L/min cardiac outputs, and 100-150beats/min heart rates are measured. Mechanical differences between expanded polytetrafluoroethylene and polyvinylchloride are investigated through biaxial strain tests. In newborn hemodynamic conditions, 0.5-1 L/min cardiac output, bileaflet valves demonstrated regurgitation rates below 20%, and two tricuspid models maintained regurgitation rates below 15% with gradients below 25 mmHg. In infant conditions, 1-3 L/min output, the regurgitation rates of trileaflet models were below 20%, with gradients consistently below 35 mmHg. The fully coapting bileaflet model showed a regurgitation rate of less than 15% and a gradient below 30 mmHg across newborn and infant conditions. A circumferential difference of less than 0.12 mm was detected between expanded polytetrafluoroethylene and polyvinylchloride. Both the fully coapting bileaflet and redundant trileaflet configurations can be integrated in the small conduits. Polyvinylchloride can be an alternative to expanded polytetrafluoroethylene tube graft in in-vitro studies, allowing visual access to assess leaflet kinematics.

Article	Year
Switching the Left and the Right Hearts: A Novel Bi-ventricle Mechanical Support Strategy with Spared Native Single-Ventricle. Annals of biomedical engineering\| PubMed ID: 37635154	2023
Optimizing percutaneous pulmonary valve implantation with patient-specific 3D-printed pulmonary artery models and hemodynamic assessment. Frontiers in cardiovascular medicine\| PubMed ID: 38259310	2023
Evaluation of the total hydrodynamic energy loss using 4D flow MRI in a case with Fontan failure. Heliyon\| PubMed ID: 38515711	2024
3D Modeling of Self-Expandable Valves for PPVI in Distinct RVOT Morphologies. Pediatric cardiology\| PubMed ID: 39923207	2025
Novel small-sized ePTFE valves for neonatal RVOT reconstruction: an in-vitro investigation. Journal of biomechanics\| PubMed ID: 40064129	2025

Ibrahim Basar Aka

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