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 hypoplastic left heart syndrome. This novel technology focuses beams of ultrasound energy precisely and accurately on targets deep in the body without damaging surrounding normal tissue. Where the beams converge, the ultrasound produces precise ablation (thermal or mechanical destruction of tissue) enabling hypoplastic left heart syndrome to be treated initially without surgery.
An important treatment component is ensuring adequate patency of an atrial septal defect which allows pulmonary venous blood returning to the left heart to be shunted to the right heart. Focused ultrasound is capable of precise mechanical tissue destruction through a process known as histotripsy, and a preclinical study has already demonstrated the ability of histotripsy to noninvasively create an atrial septal defect.
The primary options for treatment of hypoplastic left heart syndrome are surgical.
For certain patients, focused ultrasound could provide a noninvasive alternative to surgery with less risk of complications and lower cost for certain aspects of treatment.
- 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 treatment of hypoplastic left heart syndrome.
Regulatory Approval and Reimbursement
Focused ultrasound treatment for hypoplastice left heart syndrome is not yet approved by regulatory bodies or covered by medical insurance companies.
Villemain O, Kwiecinski W, Bel A, Robin J, Bruneval P, Arnal B, Tanter M, Pernot M, Messas E. Pulsed cavitational ultrasound for non-invasive chordal cutting guided by real-time 3D echocardiography. Eur Heart J Cardiovasc Imaging. 2016 Oct;17(10):1101-7. doi: 10.1093/ehjci/jew145. Epub 2016 Aug 12.
Devanagondi R1, Zhang X2, Xu Z3, Ives K4, Levin A5, Gurm H6, Owens GE7. Hemodynamic and Hematologic Effects of Histotripsy of Free-Flowing Blood: Implications for Ultrasound-Mediated Thrombolysis. J Vasc Interv Radiol. 2015 Oct;26(10):1559-65. doi: 10.1016/j.jvir.2015.03.022. Epub 2015 May 4.
M. Azmin, C. Harfield, Z. Ahmad, M. Edirisinghe, and E. Stride, “How do microbubbles and ultrasound interact? Basic physical, dynamic and engineering principles.,” Curr. Pharm. Des., vol. 18, no. 15, pp. 2118–2134, 2012.
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.
W. W. Roberts, T. L. Hall, K. Ives, J. S. Wolf Jr., J. B. Fowlkes, and C. A. Cain, “Pulsed cavitational ultrasound: A noninvasive technology for controlled tissue ablation (histotripsy) in the rabbit kidney,” J. Urol., vol. 175, no. 2, pp. 734–738, 2006.
Click here for additional references from PubMed.