Research Project:
Fully implantable patient-specific Artificial Hearts without External Power

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EC.00148

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Pekkan, Kerem
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Switching the left and the right hearts: A novel BI-ventricle mechanical support strategy with spared native single-ventricle
(Springer, 2023) Pekkan, Kerem; Yıldırım, Canberk; Şişli, Emrah; Aka, İbrahim Başar; Tuncer, Osman Nuri; Atay, Yüksel; Özbaran, Mustafa; Department of Mechanical Engineering; Yes; College of Engineering
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(2)) 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 similar to 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 similar to 5 mmHg drop in the CVP, with venous/pulmonary pulsatility reaching to similar 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.
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Effect of impeller rotational phase on the FDA blood pump velocity fields
(Wiley, 2024) Karataş, Faruk; Pekkan, Kerem; Uçak, Kağan; Department of Mechanical Engineering; Yes; College of Engineering
Background:The Food and Drug Administration (FDA) blood pump is an open-source benchmark cardiovascular device introduced for validating computational and experimental performance analysis tools. The time-resolved velocity field for the whole impeller has not been established, as is undertaken in this particle image velocimetry (PIV) study. The level of instantaneous velocity fluctuations is important, to assess the flow-induced rotor vibrations which may contribute to the total blood damage. MethodsTo document these factors, time-resolved two-dimensional PIV experiments were performed that were precisely phase-locked with the impeller rotation angle. The velocity fields in the impeller and in the volute conformed with the previous single blade passage experiments of literature. ResultsDepending on the impeller orientation, present experiments showed that volute outlet nozzle flow can fluctuate up to 34% during impeller rotation, with a maximum standard experimental uncertainty of 2.2%. Likewise, the flow fields in each impeller passage also altered in average 33.5%. Considerably different vortex patterns were observed for different blade passages, with the largest vortical structures reaching an average core radii of 7 mm. The constant volute area employed in the FDA pump design contributes to the observed velocity imbalance, as illustrated in our velocity measurements. ConclusionsBy introducing the impeller orientation parameter for the nozzle flow, this study considers the possible uncertainties influencing pump flow. Expanding the available literature data, analysis of inter-blade relative velocity fields is provided here for the first-time to the best of our knowledge. Consequently, our research fills a critical knowledge gap in the understanding of the flow dynamics of an important benchmark cardiovascular device. This study prompts the need for improved hydrodynamic designs and optimized devices to be used as benchmark test devices, to build more confidence and safety in future ventricular assist device performance assessment studies.
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Mechanical support of pulmonary blood flow as a strategy to support the norwood circulation-lumped parameter model study
(Oxford Univ Press Inc, 2022) Pekkan, Kerem; Peer, Syed Murfad; Yildirim, Canberk; Desai, Manan; Ramakrishnan, Karthik; Sinha, Pranava; Jonas, Richard; Yerebakan, Can; Department of Mechanical Engineering; Yes; College of Engineering
OBJECTIVES: We hypothesize that mechanical assistance of the pulmonary blood flow in a Norwood circulation can increase systemic blood flow and oxygen delivery. The aim of the study was to compare haemodynamics of an unassisted Norwood Blalock-Taussig shunt circulation with a mechanically assisted pulmonary flow-based Norwood circulation, using a lumped parameter computational model. METHODS: A neonatal circulatory lumped parameter model was developed to simulate a Norwood circulation with a 3.5-mm Blalock-Taussig shunt in a 3.5-kg neonate. A roller pump circulatory assist device with an inflow bladder was incorporated into the Norwood circulation to mechanically support the pulmonary circulation. Computer simulations were used to compare the haemodynamics of the assisted and unassisted circulations. Assisted and unassisted models with normal (56%) and reduced ejection fraction (30%) were compared. RESULTS: Compared to the unassisted Norwood circulation, the systemic flow in the assisted Norwood increased by 25% (ejection fraction = 56%) and 41% (ejection fraction = 30%). The central venous pressure decreased by up to 3 mmHg (both ejection fraction = 56% and ejection fraction = 30%) at a maximum pulmonary assist flow of 800 ml/min. Initiation of assisted pulmonary flow increased the arterial oxygen saturation by up to 15% and mixed venous saturation by up to 20%. CONCLUSIONS: This study demonstrates that an assisted pulmonary flow-based Norwood circulation has higher systemic flow and oxygen delivery compared to a standard Norwood Blalock-Taussig shunt circulation.
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Novel small-sized ePTFE valves for neonatal RVOT reconstruction: an in-vitro investigation
(Elsevier, 2025) Pekkan, Kerem; Aka, Ibrahim Basar; Altin, Husnu Firat; Aka, Bahaeddin Umur; Turkoz, Riza; Department of Mechanical Engineering; Yes; College of Engineering
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 mockup 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.
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Computer-generated clinical decision-making in the treatment of pulmonary atresia with intact ventricular septum
(Springer, 2024) Ödemiş, Ender; Pekkan, Kerem; Ural, Berk; Yıldırım, Canberk; Donmazov, Samir; Department of Mechanical Engineering; KUH (Koç University Hospital); Yes; College of Engineering; KUH (KOÇ UNIVERSITY HOSPITAL)
Purpose: Pulmonary atresia with intact ventricular septum is a multifactorial disease requiring complex surgeries. The treatment route is determined based on the right ventricle (RV) size, tricuspid annulus size and coronary circulation dependency of RV. Since multiple parameters influence the post-operative success, a personalized decision-making based on computed hemodynamics is hypothesized to improve the treatment efficacy. Methods: A lumped parameter cardiovascular model is developed to calculate the hemodynamics of virtual patients which are generated by statistical distribution of circulation parameters. Four cohorts each with 30 digital patients are grouped based on RV size. For each patient, biventricular and one-and-half ventricle (1.5 V) repair were applied in silico and assessed via pressure, flow and saturations computed for every organ bed. Results: Biventricular and 1.5 V repair yield significant increase in the pulmonary flow and oxygen saturation for all patients compared to the pre-operative state (p-values andlt;0.001). Approximately 30% of generated patients failed to meet the sufficient saturation and flow following biventricular repair and were directed to 1.5 V repair. However, 14% of these 1.5 V repair patients failed post-operatively, requiring Fontan completion. Based on the pre-determined hemodynamics criteria, this study implies that patients having RV sizes larger than 22 ml/m2 are likely to undergo successful biventricular repair. Conclusion: Pending further clinical trials, computational pre-interventional planning has the potential to screen patients that would not optimally fit to the traditional pathway prior to in vivo execution by providing personalized hemodynamic outcome. Statistical approach allows in silico clinical trials, useful for diseases with low patient numbers. © The Author(s) under exclusive licence to Biomedical Engineering Society 2024.

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