Fetal Surgery

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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 a variety of diseases that may be treated in utero. This novel technology focuses beams of ultrasound energy precisely and accurately on targets deep in the body without damaging surrounding normal tissue.

How it Works
Where the beams converge, focused ultrasound produces various biological effects which may enable temporary or permanent repair to be made without surgery. Much of this work is still in the preclinical phase, but some of it has progressed to early patient treatment (neonatal twin-twin reversed perfusion).

One mechanism of action is the use of ultrasound energy to destroy target tissue through cavitation (histotripsy) or thermal ablation. Similarly, this mechanism could help treat defects like twin-twin transfusion syndrome (ablation of vessels), fetal bladder obstructions and a range of CHDs (atrial-septal defects, valvuloplasty, tetralogy of fallot). However, for research to progress past the preclinical and anecdotal stages, more studies are needed to further explore safety and efficacy.

Advantages
For certain patients, focused ultrasound could provide a noninvasive alternative to surgery with less risk of complications – such as surgical wound healing or infection – at a lower cost. It can reach the desired target without damaging surrounding tissue and is repeatable, if necessary.

Clinical Trials

clinical trial in London, England, is treating patients with twin pregnancies with twin-twin perfusion abnormalities with focused ultrasound.

Regulatory Approval and Reimbursement

Focused ultrasound treatment for intra-uterine conditions are not yet approved by regulatory bodies or covered by medical insurance companies.

Notable Papers

Ichizuka K, Seo K, Izudepski T, Nagatsuka M. High-intensity focused ultrasound for noninvasive fetal therapy. J Med Ultrason (2001). 2022 Mar 12. doi: 10.1007/s10396-022-01199-2.

Raghuram H, Keunen B, Soucier N, Looi T, Pichardo S, Waspe AC, Drake JM. A robotic magnetic resonance-guided high-intensity focused ultrasound platform for neonatal neurosurgery: Assessment of targeting accuracy and precision in a brain phantom. Med Phys. 2022 Feb 17. doi: 10.1002/mp.15540.

Lindley KJ, Bairey Merz CN, Asgar AW, Bello NA, Chandra S, Davis MB, Gomberg-Maitland M, Gulati M, Hollier LM, Krieger EV, Park K, Silversides C, Wolfe NK, Pepine CJ; American College of Cardiology Cardiovascular Disease in Women Committee and the Cardio-Obstetrics Work Group. Management of Women With Congenital or Inherited Cardiovascular Disease From Pre-Conception Through Pregnancy and Postpartum: JACC Focus Seminar 2/5. J Am Coll Cardiol. 2021 Apr 13;77(14):1778-1798. doi: 10.1016/j.jacc.2021.02.026.

Davis MB, Arendt K, Bello NA, Brown H, Briller J, Epps K, Hollier L, Langen E, Park K, Walsh MN, Williams D, Wood M, Silversides CK, Lindley KJ; American College of Cardiology Cardiovascular Disease in Women Committee and the Cardio-Obstetrics Work Group. Team-Based Care of Women With Cardiovascular Disease From Pre-Conception Through Pregnancy and Postpartum: JACC Focus Seminar 1/5. J Am Coll Cardiol. 2021 Apr 13;77(14):1763-1777. doi: 10.1016/j.jacc.2021.02.033.

Shaw CJ, Rivens I, Civale J, Botting KJ, Allison BJ, Brain KL, Niu Y, Ter Haar G, Giussani DA, Lees CC. Maternal and fetal cardiometabolic recovery following ultrasound-guided high-intensity focused ultrasound placental vascular occlusion. J R Soc Interface. 2019 May 31;16(154):20190013. doi: 10.1098/rsif.2019.0013. PMID: 31039691

Shaw CJ, Rivens I, Civale J, Botting KJ, Ter Haar G, Giussani DA, Lees CC. Trans-abdominal in vivo placental vessel occlusion using High Intensity Focused Ultrasound. Sci Rep. 2018 Sep 11;8(1):13631. doi: 10.1038/s41598-018-31914-4.

Seo K, Ichizuka K, Okai T, Dohi S, Nakamura M, Hasegawa J, Matsuoka R, Yoshizawa S, Umemura SI, Nagatsuka M, Sekizawa A. Twin-Reversed Arterial Perfusion Sequence Using High-Intensity Focused Ultrasound Therapy. Ultrasound Obstet Gynecol. 2018 Aug 22. doi: 10.1002/uog.20101.

Shaw CJ, ter Haar GR, Rivens IH, Giussani DA, Lees CC. Pathophysiological mechanisms of high-intensity focused ultrasound-mediated vascular occlusion and relevance to non-invasive fetal surgery. J R Soc Interface. 2014 Mar 26;11(95):20140029.

Okai T, Ichizuka K, Hasegawa J, Matsuoka R, Nakamura M, Shimodaira K, Sekizawa A, Kushima M, Umemura S. First successful case of non-invasive in-utero treatment of twin reversed arterial perfusion sequence by high-intensity focused ultrasound. Ultrasound Obstet Gynecol. 2013 Jul;42(1):112-4.

Griffiths A, terHaar G, Rivens I, Giussani D, Lees C. High-intensity focused ultrasound in obstetrics and gynecology: the birth of a new era of noninvasive surgery? Ultraschall Med. 2012 Dec;33(7):E8-15.

Ichizuka K, Hasegawa J, Nakamura M, Matsuoka R, Sekizawa A, Okai T, Umemura S. High-intensity focused ultrasound treatment for twin reversed arterial perfusion sequence. Ultrasound Obstet Gynecol. 2012 Oct;40(4):476-8.

Click here for additional references from PubMed.

Clinical Trials