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6. TCT-467 DurAVR Biomimetic Transcatheter Aortic Valve: First-in-Human Study Results Update

Author

Meduri, Christopher, primary, Latib, Azeem, additional, Kodali, Susheel, additional, Feldt, Kari, additional, Garg, Pankaj, additional, Cavalcante, Joao, additional, Sorajja, Paul, additional, Hamid, Nadira, additional, Sathananthan, Janarthanan, additional, Poon, Karl, additional, Burns, Marcus, additional, Asgar, Anita, additional, Bapat, Vinayak, additional, and Hahn, Rebecca, additional

Published
2023
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12. List of Contributors

Author

Abbas, Samer, primary, Abdullah, Shuaib, additional, Ahmad, Hasan, additional, Ailawadi, Gorav, additional, Alkashkari, Wail, additional, Alsanjari, Osama, additional, Anderson, Jason H., additional, Askew, Judah, additional, Asmarats, Luis, additional, Athappan, Ganesh, additional, Attia, Rizwan, additional, Babaliaros, Vasilis, additional, Bae, Richard Y., additional, Baker, Charles M., additional, Banerjee, Subhash, additional, Bapat, Vinayak N., additional, Barker, Colin M., additional, Ben-Dor, Itsik, additional, Bertog, Stefan, additional, Blanke, Phillipe, additional, Block, Peter, additional, Boehm, Patrick, additional, Brecker, Stephen, additional, Brilakis, Emmanouil S., additional, Burns, Marcus, additional, Butter, Christian, additional, Cabalka, Allison K., additional, Cabuay, Barry, additional, Campbell, Alex, additional, Carroll, John D., additional, Cheung, Anson W., additional, Chhatriwalla, Adnan K., additional, Cohen, Martin, additional, Cohen, Mauricio G., additional, Corrigan, Frank, additional, Dowling, Cameron, additional, Dutta, Tanya, additional, Eleid, Mackram, additional, Farivar, Robert Saeid, additional, Feldman, Ted, additional, Flavin, Thomas, additional, Forcillo, Jessica, additional, Franke, Jennifer, additional, Gafoor, Sameer, additional, Girdauskas, Evaldas, additional, Goldberg, Steven L., additional, Gössl, Mario, additional, Guerrero, Mayra, additional, Haak, Alexander, additional, Hague, Cameron, additional, Harmel, Eva, additional, Hijazi, Ziyad, additional, Hildick-Smith, David, additional, Hofmann, Ilona, additional, Horr, Samuel E., additional, Htun, Nay M., additional, Hua (Anthony) Kueh, Shaw, additional, Jelnin, Vladimir, additional, Jones, Brandon M., additional, Joshi, Ravi, additional, Kahwash, Rami, additional, Kalra, Ankur, additional, Kamioka, Norihiko, additional, Kapadia, Samir R., additional, Kaple, Ryan K., additional, Karacsonyi, Judit, additional, Katz, Marc R., additional, Kelly, John J., additional, Kessel, Samuel, additional, Kim, Ung, additional, Kleiman, Neal S., additional, Knickelbine, Thomas, additional, Krishnaswamy, Amar, additional, Kshettry, Vibhu, additional, Kueh, Shaw-Hua, additional, Kuntijoro, Ivandito, additional, Kuwata, Shingo, additional, Leipsic, Jonathon, additional, Lerakis, Stamatios, additional, Lesser, John R., additional, Lilly, Scott M., additional, Lim, D. Scott, additional, Lin, David, additional, Maisano, Francesco, additional, Mann, Gurdeep, additional, Meduri, Christopher, additional, Mick, Stephanie, additional, Mooney, Michael, additional, Myat, Aung, additional, Naidu, Srihari S., additional, Neuss, Michael, additional, Nietlispach, Fabian, additional, Ohana, Mickaël, additional, Parastatidis, Ioannis, additional, Pasala, Tilak K.R., additional, Patel, Ateet, additional, Pearson, Paul, additional, Pedersen, Wesley R., additional, Philippon, François, additional, Pichard, Augusto, additional, Poulose, Anil, additional, Pozzoli, Alberto, additional, Price, Matthew J., additional, Rajagopal, Vivek, additional, Raphael, Claire, additional, Reardon, Michael J., additional, Regar, Evelyn, additional, Rodés-Cabau, Josep, additional, Rogers, Jason H., additional, Ruiz, Carlos E., additional, Salinger, Michael, additional, Saric, Muhamed, additional, Satler, Lowell, additional, Saw, Jacqueline, additional, Schneider, Lynelle, additional, Shah, Atman P., additional, Sharma, Rahul, additional, Sherrid, Mark Victor, additional, Shome, Joy S., additional, Sievert, Horst, additional, Singh, Gagan D., additional, Smith, Thomas W., additional, Sun, Benjamin, additional, Suradi, Hussam, additional, Tang, Gilbert H.L., additional, Taramasso, Maurizio, additional, Thakkar, Jay, additional, Thourani, Vinod H., additional, Tonne, Stacey, additional, Ungi, Imre, additional, Vaskelyte, Laura, additional, Venturini, Joseph M., additional, Vezmar, Marko, additional, Waksman, Ron, additional, Wang, Zuyue, additional, Webb, John Graydon, additional, Wiktor, Dominik M., additional, and Williams, Mathew R., additional

Published
2019
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18. ASSESSMENT OF BIOPROSTHETIC VALVE REMODELING WITH FRACTURE PROCEDURE IN VALVE-IN-VALVE TAVR BY COMPUTED TOMOGRAPHY ANGIOGRAPHY

Author

Hashimoto, Go, primary, Cavalcante, Joao, additional, Fukui, Miho, additional, Lopes, Bernardo B.C., additional, Sato, Hirotomo, additional, Schmidt, Christian, additional, Burns, Marcus, additional, Gossl, Mario, additional, Sorajja, Paul, additional, Sarano, Mauruce Enriquez, additional, Lesser, John, additional, Bapat, Vinayak, additional, and Garcia, Santiago, additional

Published
2021
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21. TCT-715 Anatomic Evaluation of Balloon-Expandable Transcatheter Aortic Valve Replacement: Computed Tomography Insights for Hypo-Attenuating Leaflet Thickening

Author

Fukui, Miho, primary, Tang, Liang, additional, Lesser, John, additional, Niikura, Hiroki, additional, Nunes, Mariana, additional, Burns, Marcus, additional, Schneider, Lynelle, additional, Han, B. Kelly, additional, Garcia, Santiago, additional, Goessl, Mario, additional, Sorajja, Paul, additional, and Cavalcante, Joao, additional

Published
2019
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22. TCT-751 Prevalence and Severity of Prosthesis-Patient Mismatch After Transcatheter Aortic Valve Replacement Defined by Computed Tomography vs. Transthoracic Echocardiography

Author

Fukui, Miho, primary, Tang, Liang, additional, Lesser, John, additional, Niikura, Hiroki, additional, Nunes, Mariana, additional, Burns, Marcus, additional, Schneider, Lynelle, additional, Han, B. Kelly, additional, Garcia, Santiago, additional, Goessl, Mario, additional, Sorajja, Paul, additional, and Cavalcante, Joao, additional

Published
2019
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28. Inventing returns.

Author

Burns, Marcus

Subjects
*INVESTORS, *TECHNOLOGICAL innovations, *LABOR supply, *ECONOMICS
Abstract

The article discusses the importance for investors to be on the lookout for signs of innovation in Australia. It is said that as the resources boom has come to an end, the country needs to adapt to new economics. It states that management teams with a focus on innovation and who operate with lean and flexible workforces are likely to prosper in the new economics. It cites the innovations made by various companies such as pizza restaurant Domino's, TPG Telecom and accounting software firm Xero.

Published
2013

29. Deformation of transcatheter heart valves with mitral valve-in-valve.

Author

Fukui M, Okada A, Burns MR, Sato H, Thao KR, Wang C, Koike H, Hamid N, Enriquez-Sarano M, Lesser JR, Cavalcante JL, Sorajja P, and Bapat VN

Subjects
Humans, Mitral Valve diagnostic imaging, Mitral Valve surgery, Treatment Outcome, Prosthesis Design, Aortic Valve surgery, Aortic Valve Stenosis surgery, Heart Valve Prosthesis, Transcatheter Aortic Valve Replacement
Abstract

Background: The use of oversizing in mitral valve-in-valve (MViV) procedures can lead to non-uniform expansion of transcatheter heart valves (THV). This may have implications for THV durability., Aims: The objective of this study was to assess the extent and predictors of THV deformation in MViV procedures., Methods: We examined 33 patients who underwent MViV with SAPIEN prostheses. The extent of THV deformation (deformation index, eccentricity, neosinus volume, asymmetric leaflet expansion and vertical deformation) and hypoattenuating leaflet thickening (HALT) were assessed using cardiac computed tomography (CT), performed prospectively at 30 days post-procedure. For descriptive purposes, the THV deformation index was calculated, with values >1.00 representing a more hourglass shape., Results: Non-uniform underexpansion of THV was common after MViV implantation, with a median expansion area of 74.0% (interquartile range 68.1-84.1) at the narrowest level and a THV deformation index of 1.21 (1.13-1.29), but circularity was maintained with eccentricity ranging from 0.24 to 0.28. The degree of oversizing was a key factor associated with greater underexpansion and a higher deformation index (β=-0.634; p<0.001; β=0.594; p<0.001, respectively). Overall, the incidence of HALT on the 30-day postprocedural CT was 27.3% (9 of 33). Most patients (32 of 33) were on anticoagulation therapy, but the prothrombin time and international normalised ratio (PT-INR) at the time of the CT scan was <2.5 in 23 of 32 patients. Among patients with a PT-INR of <2.5, HALT was predominantly observed with a high THV deformation index of ≥1.18., Conclusions: THV deformation, i.e., underexpansion and an hourglass shape, commonly occurs after MViV implantation and is negatively affected by excessive oversizing. Optimising THV expansion during MViV could potentially prevent HALT.

Published
2023
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31. Early safety and feasibility of a first-in-class biomimetic transcatheter aortic valve - DurAVR.

Author

Kodali SK, Sorajja P, Meduri CU, Feldt K, Cavalcante JL, Garg P, Hamid N, Poon KK, Settergren MRM, Burns MR, Rück A, Sathananthan J, Zajarias A, Shaburishvili T, Zirakashvili T, Zhividze M, Katchakhidze G, and Bapat VN

Subjects
Humans, Female, Aged, Aged, 80 and over, Male, Aortic Valve diagnostic imaging, Aortic Valve surgery, Prospective Studies, Feasibility Studies, Biomimetics, Treatment Outcome, Prosthesis Design, Transcatheter Aortic Valve Replacement adverse effects, Transcatheter Aortic Valve Replacement methods, Aortic Valve Stenosis surgery, Heart Valve Prosthesis
Abstract

Background: TAVI is a widely accepted treatment for patients with severe aortic stenosis (AS). Despite the adoption of diverse therapies, opportunities remain to develop technologies tailored to provide optimal acute and potential long-term benefits, particularly around haemodynamics, flow and durability., Aims: We aimed to evaluate the safety and feasibility of the DurAVR transcatheter heart valve (THV), a first-in-class biomimetic valve, in the treatment of patients with symptomatic severe AS., Methods: This was a first-in-human (FIH), prospective, non-randomised, single-arm, single-centre study. Patients with severe, symptomatic AS of any surgical risk and who were eligible for the DurAVR THV prosthesis were recruited; they were assessed at baseline, 30 days, 6 months, and 1 year post-procedure for implant success, haemodynamic performance, and safety., Results: Thirteen patients (73.9±6.4 years old, 77% female) were enrolled. The DurAVR THV was successfully implanted in 100% of cases with no device-related complications. One access site complication, one permanent pacemaker implantation, and one case of moderate aortic regurgitation occurred. Otherwise, no deaths, stroke, bleeding, reinterventions, or myocardial infarction were reported during any of the follow-up visits. Despite a mean annulus size of 22.95±1.09 mm, favourable haemodynamic results were observed at 30 days (effective orifice area [EOA] 2.00±0.17 cm 2 , and mean pressure gradient [MPG] 9.02±2.68 mmHg) and were sustained at 1 year (EOA 1.96±0.11 cm 2 , MPG 8.82±1.38 mmHg), resulting in zero patients with any degree of prosthesis-patient mismatch. Additionally, new valve performance measures derived from cardiovascular magnetic resonance displayed restoration of laminar flow, consistent with a predisease state, in conjunction with a mean coaptation length of 8.3±1.7 mm., Conclusions: Preliminary results from the FIH study with DurAVR THV demonstrate a good safety profile with promising haemodynamic performance sustained at 1 year and restoration of near-normal flow dynamics. Further clinical investigation is warranted to evaluate how DurAVR THV may play a role in addressing the challenge of lifetime management in AS patients.

Published
2023
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