Focused Ultrasound Therapy
Focused ultrasound is an early-stage, noninvasive, therapeutic technology with the potential to improve the quality of life and decrease the cost of care for patients with the need for septal perforation. This novel technology focuses beams of ultrasound energy precisely and accurately on targets deep in the body without damaging surrounding normal tissue.
The mechanism of action used is, where the beams converge, the focused ultrasound produces precise ablation (thermal or mechanical destruction) of tissue enabling the septum to be perforated without surgery.
Pilot clinical research has demonstrated the potential of focused ultrasound to accurately and repeatedly create focal perforations in atrial tissue without direct contact. Aside from its thermal ablative effects, focused ultrasound is also capable of precise mechanical tissue destruction through a process known as histotripsy. A preclinical study has already demonstrated the ability of histotripsy to noninvasively create an atrial septal defect in a canine model.
The primary options for treatment of those who need septal perforation include minimally invasive surgery.
For certain patients, focused ultrasound could provide a noninvasive alternative to surgery with less risk of complications and lower cost.
- Focused ultrasound is noninvasive, so it does not carry added concerns like surgical wound healing or infection.
- Focused ultrasound can reach the desired target without damaging surrounding tissue.
- It can be repeated, if necessary.
At the present time, there are no clinical trials recruiting patients for focused ultrasound septal perforation.
Regulatory Approval and Reimbursement
Focused ultrasound treatment for septal perforation is not yet approved by regulatory bodies or covered by medical insurance companies.
Jang KW, Tu TW, Nagle ME, Lewis BK, Burks SR, Frank JA. Molecular and histological effects of MR-guided pulsed focused ultrasound to the rat heart. J Transl Med. 2017 Dec 13;15(1):252. doi: 10.1186/s12967-017-1361-y.
Zheng M, Shentu W, Chen D, Sahn DJ, Zhou X. High-intensity focused ultrasound ablation of myocardium in vivo and instantaneous biological response. Echocardiography. 2014 Oct;31(9):1146-53. doi: 10.1111/echo.12526.
Alkins R, Huang Y, Pajek D, Hynynen K. Cavitation-based third ventriculostomy using MRI-guided focused ultrasound. J Neurosurg. 2013 Dec;119(6):1520-9. doi: 10.3171/2013.8.JNS13969.
Miller RM, Kim Y, Lin KW, Cain CA, Owens GE, Xu Z. Histotripsy cardiac therapy system integrated with real-time motion correction. Ultrasound Med Biol. 2013 Dec;39(12):2362-73. doi: 10.1016/j.ultrasmedbio.2013.08.004. Epub 2013 Sep 21.
Rong S, Woo K, Zhou Q, Zhu Q, Wu Q, Wang Q, Deng C, Liu D, Yang G, Jiang Y, Wang Z, Huang J. Septal ablation induced by transthoracic high-intensity focused ultrasound in canines. J Am Soc Echocardiogr. 2013 Oct;26(10):1228-34. doi: 10.1016/j.echo.2013.06.020. Epub 2013 Jul 25.
Takei Y, Muratore R, Kalisz A, Okajima K, Fujimoto K, Hasegawa T, Arai K, Rekhtman Y, Berry G, Di Tullio MR, Homma S. In vitro atrial septal ablation using high-intensity focused ultrasound. J Am Soc Echocardiogr. 2012 Apr;25(4):467-72.
Owens GE, Miller RM, Owens ST, Swanson SD, Ives K, Ensing G, Gordon D, Xu Z. Intermediate-term effects of intracardiac communications created noninvasively by therapeutic ultrasound (histotripsy) in a porcine model. Pediatr Cardiol. 2012 Jan;33(1):83-9. doi: 10.1007/s00246-011-0094-6. Epub 2011 Sep 11. PubMed PMID:21910018.
Xu Z, Owens G, Gordon D, Cain C, Ludomirsky A. Noninvasive creation of an atrial septal defect by histotripsy in a canine model. Circulation. 2010 Feb16;121(6):742-9. doi: 10.1161/CIRCULATIONAHA.109.889071. Epub 2010 Feb 1. PubMed PMID: 20124126; PubMed Central PMCID: PMC2834201.
Click here for additional references from PubMed.