Abstract
Background
Transcatheter aortic valve implants (TAVI) have revolutionised the treatment of elderly patients requiring aortic valve replacement. These patients often do not tolerate balloon valvuloplasty well, and a valvuloplasty balloon that would allow a degree of continued cardiac output during expansion would be beneficial. We tested such a balloon and describe our results in the sheep model.
Methods and Results
We developed a non-occlusive balloon (NOB) catheter. An acute experiment was performed where the NOB was inflated in six sheep in the aortic valve position without any attempt to arrest cardiac output. Two inflations were performed per animal: the first for 30 s and the second for 2–3 min. Standard occlusive balloons were inflated in two animals under rapid ventricular pacing to serve as controls. Mean pressure gradient across the NOB was 9.7 ± 5 mmHg during the inflations and all animals remained hemodynamically stable during NOB inflations.
Conclusions
The novel non-occlusive balloon catheter, which permitted uninterrupted cardiac output for a prolonged period without the need for pacing-induced temporary cessation of cardiac output, is both feasible and well tolerated in the acute sheep model.
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References
Ben-Dor, I., A. D. Pichard, L. F. Satler, S. A. Goldstein, A. I. Syed, M. A. Gaglia, G. Weissman, G. Maluenda, M. A. Gonzalez, K. Wakabayashi, S. D. Collins, R. Torguson, P. Okubagzi, Z. Xue, K. M. Kent, J. Lindsay, and R. Waksman. Complications and outcome of balloon aortic valvuloplasty in high-risk or inoperable patients. JACC Cardiovasc. Interv. 3(11):1150–1156, 2010.
Cribier, A., H. Eltchaninoff, and C. Tron. First human transcatheter implantation of an aortic valve prosthesis in a case of severe calcific aortic stenosis. Ann. Cardiol. Angeiol. (Paris) 52:173–175, 2003.
Daehnert, I., C. Rotzsch, M. Wiener, and P. Schneider. Rapid right ventricular pacing is an alternative to adenosine in catheter interventional procedures for congenital heart disease. Heart 90:1047–1050, 2004.
Erdoes, G., R. Basciani, C. Huber, S. Stortecky, P. Wenaweser, S. Windecker, T. Carrel, and B. Eberle. Transcranial Doppler-detected cerebral embolic load during transcatheter aortic valve implantation. Eur. J. Cardiothorac. Surg. 41:778–784, 2012.
Geske, J. B., M. W. Cullen, P. Sorajja, S. R. Ommen, and R. A. Nishimura. Assessment of left ventricular outflow gradient: Hypertrophic cardiomyopathy versus aortic valvular stenosis. JACC Cardiovasc. Interv. 5:675–681, 2012.
Iung, B., G. Baron, E. G. Butchart, F. Delahaye, C. Gohlke-Bärwolf, O. W. Levang, P. Tornos, J.-L. Vanoverschelde, F. Vermeer, E. Boersma, P. Ravaud, and A. Vahanian. A prospective survey of patients with valvular heart disease in Europe: The Euro Heart Survey on Valvular Heart Disease. Eur. Heart J. 24:1231–1243, 2003.
Keeble, T. R., A. Khokhar, M. M. Akhtar, A. Mathur, R. Weerackody, and S. Kennon. Percutaneous balloon aortic valvuloplasty in the era of transcatheter aortic valve implantation: a narrative review. Open Heart 3:e000421, 2016.
Letac, B., A. Cribier, R. Koning, and J. P. Bellefleur. Results of percutaneous transluminal valvuloplasty in 218 adults with valvular aortic stenosis. Am. J. Cardiol. 62:598–605, 1988.
Meier, B., B. Friedli, and I. Oberhänsli. Trefoil balloon for aortic valvuloplasty. Br. Heart J. 56:292–293, 1986.
Plante, S., M. van den Brand, L. C. P. van Veen, C. Di Mario, C. E. Essed, K. J. Beatt, and P. W. Serruys. Aortic valvuloplasty of calcific aortic stenosis with monofoil and trefoil balloon catheters: practical considerations. Int. J. Card. Imaging 5:249–260, 1990.
Acknowledgments
Research reported in this publication was supported by the Strategic Health Innovation Partnerships (SHIP) Unit of the South African Medical Research Council with funds received from the South African Department of Science and Technology. The authors would like to thank Dr Sariaan Weich and Dr Riaan Murray for help with the animals’ anaesthetics and Debbie Lloyd for help with data capture.
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This is to declare that all authors listed meet the authorship criteria according to the latest guidelines of the International Committee of Medical Journal Editors, and that all authors are in agreement with the manuscript.
Conflict of interest
Dr. Weich reports grants from Disa Vascular 2015, during the conduct of the study; and Kenneth Park, Matthew Proxenos and Markus Lehman are employees of the sponsor for the study [Disa Vascular 2015].
Ethical Approval
All institutional and national guidelines for the care and use of laboratory animals were followed and approved by the appropriate institutional committees.
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Weich, H.S.V.H., Marwick, P.C., Park, K.S. et al. Balloon Aortic Valvuloplasty Using a Non-Occlusive Balloon Catheter: First Animal Experience. Cardiovasc Eng Tech 11, 59–66 (2020). https://doi.org/10.1007/s13239-019-00442-1
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DOI: https://doi.org/10.1007/s13239-019-00442-1