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Individualized Cardiovascular Implants: Latest Devices, Techniques and Strategies

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A special issue of Bioengineering (ISSN 2306-5354). This special issue belongs to the section "Biomedical Engineering and Biomaterials".

Deadline for manuscript submissions: closed (31 March 2024) | Viewed by 18384

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Special Issue Editors

Dr. David Santer

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1. Ludwig Boltzmann Institute for Cardiovascular Research at the Center of Biomedical Research and Translational Surgery, Medical University of Vienna, 1090 Vienna, Austria
2. Department of Cardiac Surgery, University Hospital Basel, 4031 Basel, Switzerland
3. Medical Faculty, University of Basel, 4056 Basel, Switzerland
Interests: cardiac surgery; atrial fibrillation; surgical ablation; mechanical circulatory support; cardiopulmonary bypass; animal models; cardiac pacing; cardiac assist devices
Special Issues, Collections and Topics in MDPI journals

Dr. Karl H. Schneider

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Ludwig Boltzmann Institute for Cardiovascular Research at the Center of Biomedical Research, Medical University of Vienna, 1090 Wien, Austria
Interests: biomaterial design; tissue decellularization; 3D bioprinting; small diameter vascular grafts; cardiac patch; injectable ECM hydrogels; cell-matrix-interaction; in vitro bioreactor systems; 3D cell culture systems; biomaterial cytotoxicity; animal models
Special Issues, Collections and Topics in MDPI journals

Prof. Dr. George Truskey

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Guest Editor

Department of Biomedical Engineering, Duke University, Durham, NC 27708, USA
Interests: cardiovascular tissue engineering; mechanisms of atherogenesis; cell adhesion; cell biomechanics
Special Issues, Collections and Topics in MDPI journals

Special Issue Information

Dear Colleagues,

In recent years, cardiac surgery has become more and more of a multidisciplinary specialty. Twenty years ago, who would have thought that cardiac surgeons would specialize in interventional procedures and share the cardiac OR with cardiologists, vascular surgeons, interventional radiologists, and sometimes even biomedical engineers? New technologies and multidisciplinary strategies allow for customized scaffold designs for implants and result in innovative therapies for today's patients.

The goal of this Special Issue is to collect original papers, reviews, and case reports on new approaches to manufacturing and testing novel implants in cardiovascular research and resulting innovations in surgical therapy. It is intended to be a collection of content from the laboratory to the bedside: promising results from biomedical research such as new materials, designs, or manufacturing processes of implants, as well as minimally invasive surgical procedures, hybrid approaches, combined multidisciplinary procedures, or new techniques in cardiac surgery.

Topics of interest for this Special Issue include, but are not limited to:

3D printing of individualized cardiovascular scaffolds and implants.
Biodegradable and biologically active prostheses.
Novel devices and strategies in the treatment of cardiac disease.
Strategies for cardiac regeneration (e.g., cardiac patch).
Vascular access strategies.
Minimally invasive and interventional valve procedures.
Open surgical and endovascular management of thoracic aortic disease.
Optimized surgical treatment of coronary artery disease (e.g., total arterial revascularization, minimally invasive procedures, and hybrid coronary revascularization).
Novel devices and strategies in the treatment of cardiac arrhythmias.
Short-term and long-term cardiac assist devices.
Hybrid procedures.

Dr. David Santer
Dr. Karl H. Schneider
Prof. Dr. George Truskey
Guest Editors

Manuscript Submission Information

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Submitted manuscripts should not have been published previously, nor be under consideration for publication elsewhere (except conference proceedings papers). All manuscripts are thoroughly refereed through a single-blind peer-review process. A guide for authors and other relevant information for submission of manuscripts is available on the Instructions for Authors page. Bioengineering is an international peer-reviewed open access monthly journal published by MDPI.

Please visit the Instructions for Authors page before submitting a manuscript. The Article Processing Charge (APC) for publication in this open access journal is 2700 CHF (Swiss Francs). Submitted papers should be well formatted and use good English. Authors may use MDPI's English editing service prior to publication or during author revisions.

Keywords

cardiovascular implants
3D bioprinting cardiac patch
novel scaffold design
hybrid procedures
minimally invasive cardiac surgery
interventional valve replacement
aortic surgery
aortic interventions
valve procedures
devices

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Published Papers (11 papers)

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8 pages, 3085 KiB

Open AccessArticle

Modified Clover Technique Using Automated Suture Placement and Securing Technology in a Passive Beating Heart Model

by Severin Laengle, Aldo Suria, Thomas Poschner, Sahra Tasdelen, Antonios Pitsis, Alfred Kocher and Martin Andreas

Bioengineering 2024, 11(7), 666; https://doi.org/10.3390/bioengineering11070666 - 29 Jun 2024

Viewed by 940

Abstract

Tricuspid regurgitation (TR) is a prevalent finding in echocardiography and in case of severe disease is associated with impaired patient outcome. Clover repair offers a surgical solution that can be applied for the treatment of primary and secondary TR. An ex vivo passive beating porcine heart model was created to test a modified clover technique using automated suturing devices and to compare this approach to standard ring annuloplasty. Secondary TR was induced in 10 porcine hearts and the backflow of fluid was assessed. The primary endpoint of this study was regurgitant volume measured in mL at the site right atrial cannula. The baseline regurgitation was 43.3 ± 10.8 mL. The mean regurgitant volume was significantly reduced after all repair procedures to 22.2 ± 5.9 mL with isolated ring annuloplasty, 12 ± 3.9 mL with the modified clover, and 7.6 ± 3.4 mL with the combined procedure (p < 0.0001). The modified clover technique shows how to effectively reduce TR in an ex vivo model. This method may be suitable to facilitate tricuspid repair, especially for totally endoscopic valve surgery. Full article

(This article belongs to the Special Issue Individualized Cardiovascular Implants: Latest Devices, Techniques and Strategies)

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13 pages, 2816 KiB

Open AccessArticle

Left Ventricular Assist Device Pump Obstruction Reduces Native Heart Efficiency

by Ricardo Montes, Saniya Salim Ueckert, Vi Vu and Karen May-Newman

Bioengineering 2023, 10(12), 1403; https://doi.org/10.3390/bioengineering10121403 - 7 Dec 2023

Viewed by 1290

Abstract

Obstruction of the LVAD flow path can occur when blood clots or tissue overgrowth form within the inflow cannula, pump body, or outflow graft, and it can lead to thrombus, embolism, and stroke. The goal of this study was to measure the impact of progressive pump inflow obstruction on the pressure and flow dynamics of the LVAD-supported heart using a mock circulatory loop. Pump obstruction (PO) was produced by progressively blocking a fraction of the LVAD inlet area. Pressures, flows, and the midplane velocity field of the LV were measured for three LVAD speeds and six PO levels. Pressure and flow decreased with PO, shifting more of the flow through the aortic valve such that the total flow decreased by 6–11% and decreased the efficiency of the work of the native heart up to 60%. PO restricts diastolic flow through the LVAD, which reduces mitral inflow and decreases the strength and energy of the intraventricular vortices. The changes in flow architecture produced by PO include flow stasis and increased shear, which predispose the system to thromboembolic risk. Analysis of the contributions to external work may enable early detection, which allows time for therapeutic intervention, reducing the likelihood of pump replacement and the risk of complications. Full article

(This article belongs to the Special Issue Individualized Cardiovascular Implants: Latest Devices, Techniques and Strategies)

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22 pages, 3730 KiB

Open AccessArticle

Upscaled Skeletal Muscle Engineered Tissue with In Vivo Vascularization and Innervation Potential

by Vladislav Borisov, Laia Gili Sole, Gregory Reid, Giulia Milan, Gregor Hutter, Martin Grapow, Friedrich Stefan Eckstein, Giuseppe Isu and Anna Marsano

Bioengineering 2023, 10(7), 800; https://doi.org/10.3390/bioengineering10070800 - 4 Jul 2023

Cited by 1 | Viewed by 1655

Abstract

Engineering functional tissues of clinically relevant size (in mm-scale) in vitro is still a challenge in tissue engineering due to low oxygen diffusion and lack of vascularization. To address these limitations, a perfusion bioreactor was used to generate contractile engineered muscles of a 3 mm-thickness and a 8 mm-diameter. This study aimed to upscale the process to 50 mm in diameter by combining murine skeletal myoblasts (SkMbs) with human adipose-derived stromal vascular fraction (SVF) cells, providing high neuro-vascular potential in vivo. SkMbs were cultured on a type-I-collagen scaffold with (co-culture) or without (monoculture) SVF. Large-scale muscle-like tissue showed an increase in the maturation index over time (49.18 ± 1.63% and 76.63 ± 1.22%, at 9 and 11 days, respectively) and a similar force of contraction in mono- (43.4 ± 2.28 µN) or co-cultured (47.6 ± 4.7 µN) tissues. Four weeks after implantation in subcutaneous pockets of nude rats, the vessel length density within the constructs was significantly higher in SVF co-cultured tissues (5.03 ± 0.29 mm/mm²) compared to monocultured tissues (3.68 ± 0.32 mm/mm²) (p < 0.005). Although no mature neuromuscular junctions were present, nerve-like structures were predominantly observed in the engineered tissues co-cultured with SVF cells. This study demonstrates that SVF cells can support both in vivo vascularization and innervation of contractile muscle-like tissues, making significant progress towards clinical translation. Full article

(This article belongs to the Special Issue Individualized Cardiovascular Implants: Latest Devices, Techniques and Strategies)

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11 pages, 4082 KiB

Open AccessArticle

A Novel Percutaneous Technique for Aorto-Iliac Thrombectomy without the Risk of Embolization

by Rosalinda D’Amico, Thomas Wolff, Sabine Richarz, Lorenz Gurke, Andrej Isaak and Edin Mujagic

Bioengineering 2023, 10(7), 778; https://doi.org/10.3390/bioengineering10070778 - 29 Jun 2023

Viewed by 1018

Abstract

Classic surgical thrombectomy of the aorta and iliac arteries through an incision in the groin vessels harbors the risk of embolization to the viscero-renal as well as hypogastric arteries, while percutaneous endovascular thrombectomy techniques can lead to peripheral embolization to the lower limbs. Therefore, we describe a novel, percutaneous technique that tackles the above issues. Furthermore, we also present our initial experience using the technique. The principle of the technique is to percutaneously place large-bore sheaths in the iliac arteries that deliberately occlude the latter to protect the lower limbs from embolization. Through one of these sheaths, over wire Fogarty^® catheters can be placed and inflated in the ostia of the coeliac trunk, superior mesenteric artery, renal arteries, and hypogastric arteries as needed. A large thrombectomy balloon catheter is then used to bring any aorto-iliac thrombus into the sheaths, whereafter the thrombus is removed from the sheaths by simply deflating their valves. Additional endovascular procedures of the aorto-iliac branches can be performed as needed. We report nine procedures in 8 patients (4 males and 4 females) with a median age of 63 (53–68.5). Additional endovascular procedures were performed in 6 (66.7%) procedures. All but one procedure were technically successful, and all patients had palpable foot pulses on completion of the procedures, while no patient had clinical signs of peripheral embolization. This technique is a very valid addition to the vascular surgeon’s armamentarium when treating aorto-iliac thrombotic events because it is minimally invasive while still protecting against embolization and offering the flexibility to perform a wide range of additional endovascular procedures where needed. Full article

(This article belongs to the Special Issue Individualized Cardiovascular Implants: Latest Devices, Techniques and Strategies)

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30 pages, 9226 KiB

Open AccessArticle

One Billion hiPSC-Cardiomyocytes: Upscaling Engineered Cardiac Tissues to Create High Cell Density Therapies for Clinical Translation in Heart Regeneration

by Kiera D. Dwyer, Rajeev J. Kant, Arvin H. Soepriatna, Stephanie M. Roser, Mark C. Daley, Sharif A. Sabe, Cynthia M. Xu, Bum-Rak Choi, Frank W. Sellke and Kareen L. K. Coulombe

Bioengineering 2023, 10(5), 587; https://doi.org/10.3390/bioengineering10050587 - 13 May 2023

Cited by 4 | Viewed by 2271

Abstract

Despite the overwhelming use of cellularized therapeutics in cardiac regenerative engineering, approaches to biomanufacture engineered cardiac tissues (ECTs) at clinical scale remain limited. This study aims to evaluate the impact of critical biomanufacturing decisions—namely cell dose, hydrogel composition, and size-on ECT formation and function—through the lens of clinical translation. ECTs were fabricated by mixing human induced pluripotent stem-cell-derived cardiomyocytes (hiPSC-CMs) and human cardiac fibroblasts into a collagen hydrogel to engineer meso-(3 × 9 mm), macro- (8 × 12 mm), and mega-ECTs (65 × 75 mm). Meso-ECTs exhibited a hiPSC-CM dose-dependent response in structure and mechanics, with high-density ECTs displaying reduced elastic modulus, collagen organization, prestrain development, and active stress generation. Scaling up, cell-dense macro-ECTs were able to follow point stimulation pacing without arrhythmogenesis. Finally, we successfully fabricated a mega-ECT at clinical scale containing 1 billion hiPSC-CMs for implantation in a swine model of chronic myocardial ischemia to demonstrate the technical feasibility of biomanufacturing, surgical implantation, and engraftment. Through this iterative process, we define the impact of manufacturing variables on ECT formation and function as well as identify challenges that must still be overcome to successfully accelerate ECT clinical translation. Full article

(This article belongs to the Special Issue Individualized Cardiovascular Implants: Latest Devices, Techniques and Strategies)

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11 pages, 5045 KiB

Open AccessArticle

Impact of an Accessory for Left Ventricular Assist Devices on Device Flow and Pressure Head In Vitro

by Florian Meissner, Derya Eichelkraut, Marius Schimmel, Sven Maier, Heiko Vestner, Manuela Schoen, Martin Czerny and Wolfgang Bothe

Bioengineering 2023, 10(4), 486; https://doi.org/10.3390/bioengineering10040486 - 19 Apr 2023

Cited by 4 | Viewed by 1622

Abstract

A novel accessory directing the blood from the outflow of a left ventricular assist device (LVAD) back through the left ventricular apex and across the aortic valve allows LVAD implantation via the left ventricular apex solely but may affect the LVAD performance. We quantified the effect of the accessory on LVAD flow and pressure head in vitro. In a mock circulatory loop, a centrifugal-flow LVAD (HeartMate 3, Abbott, Abbott Park, IL, USA) with (Accessory) and without the accessory (Control) was compared under physiological conditions using a water/glycerol solution as a blood substitute. The pump was operated at 4000, 5200, and 6400 rpm and 5 different resistance levels. Flow, inlet, and outlet pressure were measured, and pressure head was calculated. Compared to the Control, flow and pressure head in the Accessory group were reduced by an overall average of 0.26 L/min and 9.9 mmHg (all speeds and resistance levels). The highest decline in flow and pressure head occurred at the lowest resistance levels. In conclusion, the accessory leads to a reduction of LVAD flow and pressure head that is enhanced by decreases in resistance. Future developments in the LVAD accessory’s design may reduce these effects and allow unimpaired LVAD performance and minimally invasive device implantation. Full article

(This article belongs to the Special Issue Individualized Cardiovascular Implants: Latest Devices, Techniques and Strategies)

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15 pages, 5075 KiB

Open AccessFeature PaperArticle

Woven Vascular Stent-Grafts with Surface Modification of Silk Fibroin-Based Paclitaxel/Metformin Microspheres

by Mengdi Liang, Fang Li, Yongfeng Wang, Hao Chen, Jingjing Tian, Zeyu Zhao, Karl H. Schneider and Gang Li

Bioengineering 2023, 10(4), 399; https://doi.org/10.3390/bioengineering10040399 - 23 Mar 2023

Cited by 6 | Viewed by 2429

Abstract

In-stent restenosis caused by tumor ingrowth increases the risk of secondary surgery for patients with abdominal aortic aneurysms (AAA) because conventional vascular stent grafts suffer from mechanical fatigue, thrombosis, and endothelial hyperplasia. For that, we report a woven vascular stent-graft with robust mechanical properties, biocompatibility, and drug delivery functions to inhibit thrombosis and the growth of AAA. Paclitaxel (PTX)/metformin (MET)-loaded silk fibroin (SF) microspheres were self-assembly synthesized by emulsification-precipitation technology and layer-by-layer coated on the surface of a woven stent via electrostatic bonding. The woven vascular stent-graft before and after coating drug-loaded membranes were characterized and analyzed systematically. The results show that small-sized drug-loaded microspheres increased the specific surface area and promoted the dissolution/release of drugs. The stent-grafts with drug-loaded membranes exhibited a slow drug-release profile more for than 70 h and low water permeability at 158.33 ± 17.56 mL/cm²·min. The combination of PTX and MET inhibited the growth of human umbilical vein endothelial cells. Therefore, it was possible to generate dual-drug-loaded woven vascular stent-grafts to achieve the more effective treatment of AAA. Full article

(This article belongs to the Special Issue Individualized Cardiovascular Implants: Latest Devices, Techniques and Strategies)

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13 pages, 2589 KiB

Open AccessArticle

Acellular Human Placenta Small-Diameter Vessels as a Favorable Source of Super-Microsurgical Vascular Replacements: A Proof of Concept

by Florian Falkner, Simon Andreas Mayer, Benjamin Thomas, Sarah Onon Zimmermann, Sonja Walter, Patrick Heimel, Wilko Thiele, Jonathan Paul Sleeman, Amir Khosrow Bigdeli, Herbert Kiss, Bruno Karl Podesser, Ulrich Kneser, Helga Bergmeister and Karl Heinrich Schneider

Bioengineering 2023, 10(3), 337; https://doi.org/10.3390/bioengineering10030337 - 7 Mar 2023

Cited by 4 | Viewed by 2012

Abstract

In this study, we aimed to evaluate the human placenta as a source of blood vessels that can be harvested for vascular graft fabrication in the submillimeter range. Our approach included graft modification to prevent thrombotic events. Submillimeter arterial grafts harvested from the human placenta were decellularized and chemically crosslinked to heparin. Graft performance was evaluated using a microsurgical arteriovenous loop (AVL) model in Lewis rats. Specimens were evaluated through hematoxylin-eosin and CD31 staining of histological sections to analyze host cell immigration and vascular remodeling. Graft patency was determined 3 weeks after implantation using a vascular patency test, histology, and micro-computed tomography. A total of 14 human placenta submillimeter vessel grafts were successfully decellularized and implanted into AVLs in rats. An appropriate inner diameter to graft length ratio of 0.81 ± 0.16 mm to 7.72 ± 3.20 mm was achieved in all animals. Grafts were left in situ for a mean of 24 ± 4 days. Decellularized human placental grafts had an overall patency rate of 71% and elicited no apparent immunological responses. Histological staining revealed host cell immigration into the graft and re-endothelialization of the vessel luminal surface. This study demonstrates that decellularized vascular grafts from the human placenta have the potential to serve as super-microsurgical vascular replacements. Full article

(This article belongs to the Special Issue Individualized Cardiovascular Implants: Latest Devices, Techniques and Strategies)

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13 pages, 911 KiB

Open AccessArticle

by Constantin Mork, Raphael Twerenbold, Brigitta Gahl, Friedrich Eckstein, Raban Jeger, Christoph Kaiser and Oliver Reuthebuch

Bioengineering 2023, 10(2), 156; https://doi.org/10.3390/bioengineering10020156 - 24 Jan 2023

Viewed by 1469

Abstract

Transapical transcatheter aortic valve implantation (TA-TAVI) is generally considered to be associated with increased morbidity and mortality compared with transfemoral transcatheter aortic valve implantation TAVI (TF-TAVI). We aimed to compare different patient risk profiles, access-related complications, and long-term survival using inverse probability treatment weighting. This is a retrospective, single-center analysis of 925 consecutive patients with aortic valve stenosis undergoing TF-TAVI (n = 802) or TA-TAVI (n = 123) at the University Hospital Basel, Switzerland, as a single procedure between September 2011 and August 2020. Baseline characteristics revealed a higher perioperative risk as reflected in the EuroSCORE II (geometric mean 2.3 (95% confidence interval (CI) 2.2 to 2.4) vs. 3.7 (CI 3.1 to 4.5); before inverse probability of treatment weighting (IPTW) p < 0.001) in the transfemoral than in the transapical group, respectively. After 30 days, TF-TAVI patients had a higher incidence of any bleeding than TA-TAVI patients (TF-TAVI n = 146 vs. TA-TAVI n = 15; weighted hazard ratio (HR) 0.52 (0.29 to 0.95); p = 0.032). After 5 years, all-cause mortality did not differ between the two groups (TF-TAVI n = 162 vs. TA-TAVI n = 45; weighted HR 1.31, (0.92 to 1.88); p = 0.138). With regard to our data, we could demonstrate, despite a higher perioperative risk, the short- and long-term safety and efficacy of the transapical approach for TAVI therapies. Though at higher perioperative risk, transapically treated patients suffered from less bleeding or vascular complications than transfemorally treated patients. It is of utmost interest that 5-year mortality did not differ between the groups. Full article

(This article belongs to the Special Issue Individualized Cardiovascular Implants: Latest Devices, Techniques and Strategies)

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11 pages, 3924 KiB

Open AccessArticle

Ultrasound-Guided Percutaneous Arteriovenous Fistula Creation Simulation Training in a Lifelike Flow Model

by Andrej Isaak, Thomas Wolff, Andrei Zdoroveac, Fadi Taher, Lorenz Gürke, Sabine Richarz and Shuaib Akifi

Bioengineering 2022, 9(11), 659; https://doi.org/10.3390/bioengineering9110659 - 6 Nov 2022

Cited by 2 | Viewed by 1721

Abstract

Objectives: To assess the feasibility and training effect of simulation training for ultrasound-guided percutaneous arteriovenous fistula (pAVF) creation in a lifelike flow model. Methods: Twenty vascular trainees and specialists were shown an instructional video on creating a pAVF in a dedicated flow model and then randomized to a study or control group. The procedure was divided into five clearly defined steps. Two observers rated the performance on each step, and the time to perform the exercise was recorded. The study group participants underwent supervised hands-on training on the model before performing a second rated pAVF creation. All participants subsequently completed a feedback questionnaire. Results: After supervised simulation training, the study groups participants increased their mean performance rating from 2.2 ± 0.9 to 3.2 ± 0.7. A mean of 3.8 ± 0.8 procedure steps was accomplished independently (control group 2.1 ± 1.4; p < 0.05). The time taken to perform the procedure was 15.6 ± 3.8 min in the study group (control group 27.2 ± 7.3, p < 0.05). The participants with previous experience in ultrasound-guided vascular procedures (n = 5) achieved higher overall mean scores 3.0 ± 0.8 and accomplished more steps without assistance (2.0 ± 1.0) during the simulation training compared to their inexperienced peers (1.5 ± 0.3 and 0.8 ± 0.4, respectively). The feedback questionnaire revealed that the study group participants strongly agreed (n = 7) or agreed (n = 3) that training on the simulation model improved their skills regarding catheter handling. Conclusions: The study group participants increased their overall performance after training on the simulator. More experienced attendees performed better from the beginning, indicating the model to be lifelike and a potential skill assessment tool. Simulation training for pAVF creation using a lifelike model may be an intermediate step between acquiring ultrasound and theoretical pAVF skills and procedure guidance in theatre. However, this type of training is limited by its reliance on the simulator quality, demonstration devices and costs. Full article

(This article belongs to the Special Issue Individualized Cardiovascular Implants: Latest Devices, Techniques and Strategies)

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13 pages, 1279 KiB

Open AccessPerspective

Cerebral Protection Strategies in Aortic Arch Surgery—Past Developments, Current Evidence, and Future Innovation

by Paul Werner, Martin Winter, Stephané Mahr, Marie-Elisabeth Stelzmueller, Daniel Zimpfer and Marek Ehrlich

Bioengineering 2024, 11(8), 775; https://doi.org/10.3390/bioengineering11080775 - 31 Jul 2024

Viewed by 804

Abstract

Surgery of the aortic arch remains a complex procedure, with neurological events such as stroke remaining its most dreaded complications. Changes in surgical technique and the continuous innovation in neuroprotective strategies have led to a significant decrease in cerebral and spinal events. Different modes of cerebral perfusion, varying grades of hypothermia, and a number of pharmacological strategies all aim to reduce hypoxic and ischemic cerebral injury, yet there is no evidence indicating the clear superiority of one method over another. While surgical results continue to improve, novel hybrid and interventional techniques are just entering the stage and the question of optimal neuroprotection remains up to date. Within this perspective statement, we want to shed light on the current evidence and controversies of cerebral protection in aortic arch surgery, as well as what is on the horizon in this fast-evolving field. We further present our institutional approach as a large tertiary aortic reference center. Full article

(This article belongs to the Special Issue Individualized Cardiovascular Implants: Latest Devices, Techniques and Strategies)

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