Journal of Ultrasound in Medicine

Volume 42, Issue 12 pp. E68-E73

Guidance paper

AIUM Official Statement for the Statement on Biological Effects of Therapeutic Ultrasound

First published: 16 August 2023

https://doi.org/10.1002/jum.16315

References

• 1Fowlkes JB, Bioeffects Committee of the American Institute of Ultrasound in Medicine. American Institute of Ultrasound in Medicine consensus report on potential bioeffects of diagnostic ultrasound. J Ultrasound Med 2008; 27: 503–515. https://doi.org/10.7863/jum.2008.27.4.503.
  10.7863/jum.2008.27.4.503

  PubMed Web of Science® Google Scholar
• 2 International Electrotechnical Commission. Particular Requirements for the Basic Safety and Essential Performance of Ultrasonic Medical Diagnostic and Monitoring Equipment. Edition 2.1. Geneva: IEC; 2015.
  Google Scholar
• 3 Recommended Maximum Scanning Times for Displayed Thermal Index (TI) Values. Laurel: American Institute of Ultrasound in Medicine. https://www.aium.org/officialStatements/65. Accessed April 18, 2022.
  Google Scholar
• 4Miller DL, Smith NB, Bailey MR, Czarnota GJ, Hynynen K, Makin IRS. Overview of therapeutic ultrasound applications and safety considerations. J Ultrasound Med 2012; 31: 623–634. https://doi.org/10.7863/jum.2012.31.4.623.
  10.7863/jum.2012.31.4.623

  PubMed Web of Science® Google Scholar
• 5 EKOS™ Endovascular System. Coding & Payment Guide. Maple Grove: Boston Scientific. 2022. https://www.bostonscientific.com/content/dam/bostonscientific/pi/portfolio-group/VascularSurgery/ekos/recent-updates/EKOS-Reimbursement-Coding-Guide-vF-PI-874704-AA.pdf. Accessed April 18, 2022.
  Google Scholar
• 6 Summary of Data Changes Integrated OCE v 16.0. Baltimore: Centers for Medicare & Medicaid Services. https://www.cms.gov/files/document/finalsumofdatachngsspeccms-report508pdf-0. Accessed April 18, 2022.
  Google Scholar
• 7 Magnetic Resonance Guided Focused Ultrasound Surgery System (MRgFUS) for the treatment of neurologic conditions. Baltimore, MD: Centers for Medicare & Medicaid Services. https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=37790&ver=15&ContrId=238&ContrVer=2&CntrctrSelected=238*2&Cntrctr=238&name=&DocType=4&bc=AAAAAACAAAAA. Accessed April 10, 2022.
  Google Scholar
• 8 Billing and Coding: Magnetic Resonance Guided Focused Ultrasound Surgery System (MRgFUS) for the Treatment of Neurologic Conditions. Baltimore: Centers for Medicare & Medicaid Services. https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleid=58323&ver=4&keyword=ultrasoundsurgery&keywordType=starts&areaId=all&docType=NCA,CAL,NCD,MEDCAC,TA,MCD,6,3,5,1,F,P&contractOption=all&sortBy=relevance&bc=1. Accessed April 18, 2022.
  Google Scholar
• 9 Magnetic Resonance Guided Focused Ultrasound Surgery System (MRgFUS) for the Treatment of Neurologic Conditions. Baltimore, MD: Centers for Medicare & Medicaid Services. https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=37790&ver=15&. Accessed April 18, 2022.
  Google Scholar
• 10 Salvage High-Intensity Focused Ultrasound (HIFU) Treatment in Prostate Cancer (PCa). Baltimore: Centers for Medicare & Medicaid Services. https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=38262&ver=3. Accessed April 18, 2022.
  Google Scholar
• 11Nyborg WL, Carson PL, Carstensen EL, et al. Exposure Criteria for Medical Diagnostic Ultrasound: II. Criteria Based on All Known Mechanisms; NCRP Report No. 140. 1st ed. Bethesda: National Council on Radiation Protection and Measurements; 2002.
  Google Scholar
• 12Dalecki D, Carstensen EL, Parker KJ, Bacon DR. Absorption of finite amplitude focused ultrasound. J Acoust Soc Am 1991; 89: 2435.
  10.1121/1.400976

  CAS PubMed Web of Science® Google Scholar
• 13Nyborg WL. Acoustic streaming due to attenuated plane waves. J Acoust Soc Am 1953; 25: 68.
  10.1121/1.1907010

  Web of Science® Google Scholar
• 14Miller DL, Brayman AA, Holland CK, Wu J. Bioeffects considerations for diagnostic ultrasound contrast agents. J Ultrasound Med 2008; 27: 611–632.
  10.7863/jum.2008.27.4.611

  PubMed Web of Science® Google Scholar
• 15Apfel RE. Acoustic Cavitation. In: PD Edmonds (ed). Methods in Experimental Physics: Ultrasonics. 1st ed. New York: Academic Press, Inc; 1981: 355-411.
  Google Scholar
• 16Flynn HG. Physics of acoustic cavitation in liquids. In: WP Mason (ed). Physical Acoustics. 1st ed. New York: Academic Press, Inc.; 1964: 58-172.
  Google Scholar
• 17Lin PH, Annambhotla S, Bechara CF, et al. Comparison of percutaneous ultrasound-accelerated thrombolysis versus catheter-directed thrombolysis in patients with acute massive pulmonary embolism. Vascular 2009; 17: 137–147. https://doi.org/10.2310/6670.2009.00063.
  10.2310/6670.2009.00063

  PubMed Web of Science® Google Scholar
• 18Deffieux T, Younan Y, Wattiez N, Tanter M, Pouget P, Aubry JF. Low-intensity focused ultrasound modulates monkey visuomotor behavior. Curr Biol 2013; 23: 2430–2433. https://doi.org/10.1016/j.cub.2013.10.029.
  10.1016/j.cub.2013.10.029

  CAS PubMed Web of Science® Google Scholar
• 19King RL, Brown JR, Newsome WT, Pauly KB. Effective parameters for ultrasound-induced in vivo neurostimulation. Ultrasound Med Biol 2013; 39: 312–331. https://doi.org/10.1016/j.ultrasmedbio.2012.09.009.
  10.1016/j.ultrasmedbio.2012.09.009

  PubMed Web of Science® Google Scholar
• 20 Ultrasound Stimulation for Nonunion Fracture Healing. Baltimore, MD: Centers for Medicare & Medicaid Services. https://www.cms.gov/medicare-coverage-database/view/ncacal-decision-memo.aspx?proposed=N&ncaid=135. Accessed April 18, 2022.
  Google Scholar
• 21Sapareto SA, Dewey WC. Thermal dose determination in cancer therapy. Int J Radiat Oncol 1984; 10: 787–800.
  10.1016/0360-3016(84)90379-1

  CAS PubMed Web of Science® Google Scholar
• 22 Statement on Biological Effects of Ultrasound In Vivo. Laurel: American Institute of Ultrasound in Medicine. https://www.aium.org/resources/official-statements/view/statement-on-biological-effects-in-tissues-with-ultrasound-contrast-agents-2. Accessed April 18, 2022.
  Google Scholar
• 23Hurwitz MD, Kaplan ID, Hansen JL. Hyperthermia combined with radiation in treatment of locally advanced prostate cancer is associated with a favourable toxicity profile. Int J Hyperthermia 2005; 21: 649–656. https://doi.org/10.1080/02656730500331967.
  10.1080/02656730500331967

  CAS PubMed Web of Science® Google Scholar
• 24Wang S, Zderic V, Frenkel V. Extracorporeal, low-energy focused ultrasound for noninvasive and nondestructive targeted hyperthermia. Future Oncol 2010; 6: 1497–1511. https://doi.org/10.2217/fon.10.101.
  10.2217/fon.10.101

  PubMed Web of Science® Google Scholar
• 25Chopra R, Tang K, Burtnyk M, et al. Analysis of the spatial and temporal accuracy of heating in the prostate gland using transurethral ultrasound therapy and active MR temperature feedback. Phys Med Biol 2009; 54: 2615–2633.
  10.1088/0031-9155/54/9/002

  PubMed Web of Science® Google Scholar
• 26Agrawal M, Garg K, Samala R, Rajan R, Naik V, Singh M. Outcome and complications of MR guided focused ultrasound for essential tremor: a systematic review and meta-analysis. Front Neurol 2021; 12:654711. https://doi.org/10.3389/fneur.2021.654711.
  10.3389/fneur.2021.654711

  PubMed Web of Science® Google Scholar
• 27Fishman PS, Fischell JM. Focused ultrasound mediated opening of the blood-brain barrier for neurodegenerative diseases. Front Neurol 2021; 12:749047. https://doi.org/10.3389/fneur.2021.749047.
  10.3389/fneur.2021.749047

  PubMed Web of Science® Google Scholar
• 28Bruno F, Catalucci A, Arrigoni F, et al. An experience-based review of HIFU in functional interventional neuroradiology: transcranial MRgFUS thalamotomy for treatment of tremor. Radiol Med 2020; 125: 877–886. https://doi.org/10.1007/s11547-020-01186-y.
  10.1007/s11547-020-01186-y

  PubMed Web of Science® Google Scholar
• 29Huisman M, ter Haar G, Napoli A, et al. International consensus on use of focused ultrasound for painful bone metastases: current status and future directions. Int J Hyperthermia 2015; 31: 251–259. https://doi.org/10.3109/02656736.2014.995237.
  10.3109/02656736.2014.995237

  PubMed Web of Science® Google Scholar
• 30Azizi M, Sanghvi K, Saxena M, et al. Ultrasound renal denervation for hypertension resistant to a triple medication pill (RADIANCE-HTN TRIO): a randomised, multicentre, single-blind, sham-controlled trial. Lancet 2021; 397: 2476–2486. https://doi.org/10.1016/S0140-6736(21)00788-1.
  10.1016/S0140-6736(21)00788-1

  CAS PubMed Web of Science® Google Scholar
• 31Xu Z, Hall TL, Vlaisavljevich E, Lee FT. Histotripsy: the first noninvasive, non-ionizing, non-thermal ablation technique based on ultrasound. Int J Hyperthermia 2021; 38: 561–575. https://doi.org/10.1080/02656736.2021.1905189.
  10.1080/02656736.2021.1905189

  CAS PubMed Web of Science® Google Scholar
• 32Bader KB, Vlaisavljevich E, Maxwell AD. For whom the bubble grows: physical principles of bubble nucleation and dynamics in histotripsy ultrasound therapy. Ultrasound Med Biol 2019; 45: 1056–1080. https://doi.org/10.1016/j.ultrasmedbio.2018.10.035.
  10.1016/j.ultrasmedbio.2018.10.035

  PubMed Web of Science® Google Scholar
• 33Bijgaart RJE, Eikelenboom DC, Hoogenboom M, Fütterer JJ, Brok MH, Adema GJ. Thermal and mechanical high-intensity focused ultrasound: perspectives on tumor ablation, immune effects and combination strategies. Cancer Immunol Immunother 2016; 66: 247–258.
  10.1007/s00262-016-1891-9

  PubMed Web of Science® Google Scholar
• 34Cleveland RO, McAteer JA. The physics of shock wave litotripsy. In: AD Smith, GH Badlani, GM Preminger, LR Kavoussi (eds). Smith's Textbook of Endourology. 2nd ed. Hoboken: Wiley-Blackwell; 2006: 527-558.
  Google Scholar
• 35Messas E, Ijsselmuiden A, Goudot G, et al. Safety, feasibility and performance of Valvosoft non-invasive ultrasound therapy in patients with severe symptomatic calcific aortic valve stenosis. First-in-man. Eur Heart J 2020; 41:ehaa946.1932. https://doi.org/10.1093/ehjci/ehaa946.1932.
  10.1093/ehjci/ehaa946.1932

  PubMed Web of Science® Google Scholar
• 36Ali ZA, Nef H, Escaned J, et al. Safety and effectiveness of coronary intravascular lithotripsy for treatment of severely calcified coronary stenoses: the disrupt CAD II study. Circ Cardiovasc Interv 2019; 12: 1–10. https://doi.org/10.1161/CIRCINTERVENTIONS.119.008434.
  10.1161/CIRCINTERVENTIONS.119.008434

  Web of Science® Google Scholar
• 37Rassweiler JJ, Knoll T, Köhrmann KU, et al. Shock wave technology and application: an update. Eur Urol 2011; 59: 784–796. https://doi.org/10.1016/j.eururo.2011.02.033.
  10.1016/j.eururo.2011.02.033

  PubMed Web of Science® Google Scholar
• 38Bader KB, Holland CK. Gauging the likelihood of stable cavitation from ultrasound contrast agents. Phys Med Biol 2013; 58: 127–144. https://doi.org/10.1088/0031-9155/58/1/127.
  10.1088/0031-9155/58/1/127

  PubMed Web of Science® Google Scholar
• 39Kooiman K, Roovers S, Langeveld SAG, et al. Ultrasound-responsive cavitation nuclei for therapy and drug delivery. Ultrasound Med Biol 2020; 46: 1296–1325. https://doi.org/10.1016/j.ultrasmedbio.2020.01.002.
  10.1016/j.ultrasmedbio.2020.01.002

  PubMed Web of Science® Google Scholar
• 40Exner AA, Kolios MC. Bursting microbubbles: how nanobubble contrast agents can enable the future of medical ultrasound molecular imaging and image-guided therapy. Curr Opin Colloid Interface Sci 2021; 54:101463. https://doi.org/10.1016/j.cocis.2021.101463.
  10.1016/j.cocis.2021.101463

  CAS PubMed Web of Science® Google Scholar
• 41Sheeran PS, Dayton PA. Phase-change contrast agents for imaging and therapy. Curr Pharm Des 2012; 18: 2152–2165. https://doi.org/10.2174/138161212800099883.
  10.2174/138161212800099883

  CAS PubMed Web of Science® Google Scholar
• 42Thomas RG, Jonnalagadda US, Kwan JJ. Biomedical applications for gas-stabilizing solid cavitation agents. Langmuir 2019; 35: 10106–10115. https://doi.org/10.1021/acs.langmuir.9b00795.
  10.1021/acs.langmuir.9b00795

  CAS PubMed Web of Science® Google Scholar
• 43Collis J, Manasseh R, Liovic P, et al. Cavitation microstreaming and stress fields created by microbubbles. Ultrasonics 2010; 50: 273–279.
  10.1016/j.ultras.2009.10.002

  CAS PubMed Web of Science® Google Scholar
• 44Sutton JT, Haworth KJ, Pyne-Geithman G, Holland CK. Ultrasound-mediated drug delivery for cardiovascular disease. Expert Opin Drug Deliv 2013; 10: 573–592.
  10.1517/17425247.2013.772578

  CAS PubMed Web of Science® Google Scholar
• 45Hynynen K, McDannold N, Vykhodtseva N, Jolesz FA. Noninvasive MR imaging-guided focal opening of the blood-brain barrier in rabbits. Radiology 2001; 220: 640–646.
  10.1148/radiol.2202001804

  CAS PubMed Web of Science® Google Scholar
• 46Carpentier A, Canney M, Vignot A, et al. Clinical trial of blood-brain barrier disruption by pulsed ultrasound. Sci Transl Med 2016; 8: 1–9. https://doi.org/10.1126/scitranslmed.aaf6086.
  10.1126/scitranslmed.aaf6086

  CAS Web of Science® Google Scholar
• 47Idbaih A, Canney M, Belin L, et al. Safety and feasibility of repeated and transient blood-brain barrier disruption by pulsed ultrasound in patients with recurrent glioblastoma. Clin Cancer Res 2019; 25: 3793–3801. https://doi.org/10.1158/1078-0432.CCR-18-3643.
  10.1158/1078-0432.CCR-18-3643

  CAS PubMed Web of Science® Google Scholar
• 48Mainprize T, Lipsman N, Huang Y, et al. Blood-brain barrier opening in primary brain tumors with non-invasive MR-guided focused ultrasound: a clinical safety and feasibility study. Sci Rep 2019; 9: 1–7. https://doi.org/10.1038/s41598-018-36340-0.
  10.1038/s41598-018-36340-0

  CAS PubMed Web of Science® Google Scholar
• 49Lipsman N, Meng Y, Bethune AJ, et al. Blood–brain barrier opening in Alzheimer's disease using MR-guided focused ultrasound. Nat Commun 2018; 9: 1–8. https://doi.org/10.1038/s41467-018-04529-6.
  10.1038/s41467-018-04529-6

  CAS PubMed Web of Science® Google Scholar
• 50Epelbaum S, Burgos N, Canney M, et al. Pilot study of repeated blood-brain barrier disruption in patients with mild Alzheimer's disease with an implantable ultrasound device. Alzheimers Res Ther 2022; 14: 1–13. https://doi.org/10.1186/s13195-022-00981-1.
  10.1186/s13195-022-00981-1

  PubMed Web of Science® Google Scholar
• 51Banerji U, Tiu CD, Curcean A, et al. Phase I trial of acoustic cluster therapy (ACT) with chemotherapy in patients with liver metastases of gastrointestinal origin (ACTIVATE study). J Clin Oncol 2021; 39:TPS3145. https://doi.org/10.1200/JCO.2021.39.15\_suppl.TPS3145.
  10.1200/JCO.2021.39.15_suppl.TPS3145

  Web of Science® Google Scholar
• 52Lyon PC, Gray MD, Mannaris C, et al. Safety and feasibility of ultrasound-triggered targeted drug delivery of doxorubicin from thermosensitive liposomes in liver tumours (TARDOX): a single-centre, open-label, phase 1 trial. Lancet Oncol 2018; 19: 1027–1039. https://doi.org/10.1016/S1470-2045(18)30332-2.
  10.1016/S1470-2045(18)30332-2

  CAS PubMed Web of Science® Google Scholar
• 53Deng CX, Sieling F, Pan H, Cui J. Ultrasound-induced cell membrane porosity. Ultrasound Med Biol 2004; 30: 519–526. https://doi.org/10.1016/j.ultrasmedbio.2004.01.005.
  10.1016/j.ultrasmedbio.2004.01.005

  PubMed Web of Science® Google Scholar
• 54Derieppe M, Rojek K, Escoffre JM, de Senneville BD, Moonen C, Bos C. Recruitment of endocytosis in sonopermeabilization-mediated drug delivery: a real-time study. Phys Biol 2015; 12:046010. https://doi.org/10.1088/1478-3975/12/4/046010.
  10.1088/1478-3975/12/4/046010

  PubMed Web of Science® Google Scholar
• 55Fekri F, Abousawan J, Bautista S, et al. Targeted enhancement of flotillin-dependent endocytosis augments cellular uptake and impact of cytotoxic drugs. Sci Rep 2019; 9: 1–15. https://doi.org/10.1038/s41598-019-54062-9.
  10.1038/s41598-019-54062-9

  CAS PubMed Web of Science® Google Scholar
• 56Mathias W, Tsutsui JM, Tavares BG, et al. Sonothrombolysis in ST-segment elevation myocardial infarction treated with primary percutaneous coronary intervention. J Am Coll Cardiol 2019; 73: 2832–2842. https://doi.org/10.1016/j.jacc.2019.03.006.
  10.1016/j.jacc.2019.03.006

  PubMed Web of Science® Google Scholar
• 57Rieke V, Butts PK. MR thermometry. J Magn Reson Imaging 2008; 27: 376–390.
  10.1002/jmri.21265

  PubMed Web of Science® Google Scholar
• 58Hall T, Fowlkes J, Cain C. A real-time measure of cavitation induced tissue disruption by ultrasound imaging backscatter reduction. Ultrason Ferroelectr Freq Control IEEE Trans 2007; 54: 569–575.
  10.1109/TUFFC.2007.279

  PubMed Web of Science® Google Scholar
• 59Eranki A, Farr N, Partanen A, et al. Mechanical fractionation of tissues using microsecond-long HIFU pulses on a clinical MR-HIFU system. Int J Hyperthermia 2018; 34: 1213–1224. https://doi.org/10.1080/02656736.2018.1438672.
  10.1080/02656736.2018.1438672

  PubMed Web of Science® Google Scholar
• 60Rouvière O, Souchon R, Salomir R, Gelet A, Chapelon JY, Lyonnet D. Transrectal high-intensity focused ultrasound ablation of prostate cancer: effective treatment requiring accurate imaging. Eur J Radiol 2007; 63: 317–327.
  10.1016/j.ejrad.2007.06.026

  PubMed Web of Science® Google Scholar
• 61Serres-Creixams X, Vidal-Jove J, Ziemlewicz TJ, et al. 2021 contrast-enhanced ultrasound: a useful tool to study and monitor hepatic tumors treated with histotripsy. IEEE Trans Ultrason Ferroelectr Freq Control 2021; 68: 2853–2860.
  10.1109/TUFFC.2021.3073540

  PubMed Web of Science® Google Scholar

Volume42, Issue12

December 2023

Pages E68-E73

• References

• Related

• Information

Close Figure Viewer

Previous FigureNext Figure

Caption

Download PDF