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High-intensity focused ultrasound (HIFU) is a non-surgical and noninvasive treatment modality that depends on external ultrasound energy sources that induce focused mass ablation and protein degeneration in the treatment area via thermal energy penetration under the intact skin. We aim in our study to collectively evaluate the safety of HIFU for the treatment of different obstetric and gynecological diseases in the literature. We searched PubMed, Scopus, and Science Direct databases, without restriction on date or language, from the inception of these databases until January 20, 2024. We also examined the references of the included studies in the Mendeley archive for eligible articles. We found a total of 706 studies. After the screening and selection process, 56 participants were included. Our dichotomous outcomes were pooled in our single-arm meta-analysis as risk ratio (RR) and with 95% confidence interval (CI) while our continuous outcomes were pooled as mean change and 95% CIs. Fixed- or random-effects models were applied depending on the heterogeneity detected. Our systematic review and meta-analysis included 56 studies including 11.740 patients. Depending on the Society of Interventional Radiology (SIR) classification for adverse effects. The results of this meta-analysis for the type A category that did not require clinical intervention found that pain in the treatment site estimated RR with 95% CI: 0.61 (0.33, 0.89), abnormal vaginal discharge 0.16 (0.073, 0.24), low-grade fever (<38 [degrees]C) 0.005 (0.002, 0.009). Sensory abnormalities of the lower limbs were examined in 3390 individuals and observed in only 19 patients who experienced gradual relief of symptoms within one month after treatment. Regarding SIR type B, 99 of a total of 6.437 patients had small vesicles and superficial burns with pooled RR and 95% CI: 0.012 (0.007, 0.018). In terms of groin or perianal and lower abdominal pain, our RRs with 95% CIs were 0.1 (0.067, 0.13) and 0.38 (0.25, 0.51). However, vaginal bleeding was detected in only 32 out of a total of 3.017. Major adverse events like lumber disc herniation, thrombocytopenia, and renal failure, were unmentionable. Additionally, our included studies did not record any deaths. HIFU, either alone or in combination with oxytocin or any other enhancing agent, is safe for patients with different gynecological and obstetric diseases. In terms of efficacy, it showed promising results compared with traditional treatment lines. To our knowledge, we are the first and most comprehensive meta-analysis in the literature that has studied the different safety outcomes related to HIFU as a treatment modality for different obstetric and gynecological diseases with a very large sample size, making our evidence strong and less attributed to errors. Keywords: HIFU, ectopic pregnancy, endometriosis, gestational trophoblastic diseases, adenomyosis Y ksek yogunluklu odaklanmis ultrason (HIFU), saglam deri altina termal enerji n fuzu yoluyla tedavi alaninda hedeflenmis kitle ablasyonunu ve protein dejenerasyonunu tetikleyen harici ultrason enerji kaynaklarina dayanan, cerrahi olmayan ve invazif olmayan bir tedavi y ntemidir. alismamizda literat rdeki farkli obstetrik ve jinekolojik hastaliklarin tedavisinde HIFU g venligini toplu olarak degerlendirmeyi ama ladik. PubMed, Scopus ve Science Direct veritabanlarini, bu veri tabanlarinin baslangicindan 20 Ocak 2024'e kadar tarih ve dil sinirlamasi olmaksizin arastirdik. Ayrica uygun makaleler i in Mendeley arsivine dahil edilen alismalarin referanslarini da inceledik. Toplam 706 alisma bulduk. Eleme ve se me s recinin ardindan 56 katilimci dahil edildi. Ikili sonu larimiz tek kollu meta-analizimizde risk orani (RR) seklinde ve %95 g ven araligi (GA) ile bir araya getirilirken, s rekli sonu larimiz ortalama degisiklik seklinde ve %95 GA ile bir araya getirildi. Tespit edilen heterojenlige bagli olarak sabit veya rastgele etki modelleri uygulandi. Sistematik incelememiz ve meta-analizimiz 11.740 hastanin dahil oldugu 56 alismayi i eriyordu. Olumsuz etkiler Girisimsel Radyoloji Dernegi'nin (SIR) siniflandirmasina g re siniflandirildi. Klinik m dahale gerektirmeyen tip A kategorisi i in bu meta-analizin sonu larina g re tedavi b lgesindeki agrinin %95 GA ile tahmin edilen RR degeri 0,61 (0,33, 0,89), anormal vajinal akintinin RR degeri 0,16 (0,073, 0,24) ve d s k dereceli atesin (<38 [degrees]C) RR degeri 0,005 (0,002, 0,009) idi. Alt ekstremitelerdeki duyusal anormallikler 3.390 kiside incelendi ve tedaviden sonraki bir ay i inde semptomlarin kademeli olarak azaldigi yalnizca 19 hastada g zlemlendi. SIR tip B kategorisi ile ilgili olarak, toplam 6.437 hastanin 99'unda k k vezik ller ve y zeysel yaniklarin %95 GA ile havuzlanmis RR degeri 0,012 (0,007, 0,018) olarak saptandi. Kasik agrisi veya perianal agri ve alt karin agrisi a isindan %95 GA ile RR degerleri 0,1 (0,067, 0,13) ve 0,38 (0,25, 0,51) idi. Ancak toplam 3.017 olgunun sadece 32'sinde vajinal kanama tespit edildi. Lomber disk hernisi, trombositopeni ve b brek yetmezligi gibi nemli yan etkilere rastlanmadi. Ayrica derledigimiz alismalarda herhangi bir l m kaydedilmedi. HIFU, tek basina veya oksitosin veya baska herhangi bir g lendirici ajanla kombinasyon halinde, farkli jinekolojik ve obstetrik hastaliklari olan hastalar i in g venlidir. Etkinlik a isindan geleneksel tedavi y ntemleriyle karsilastirildiginda HIFU mit verici sonu lar g stermistir. Bildigimiz kadariyla, bu meta-analiz farkli obstetrik ve jinekolojik hastaliklar i in bir tedavi y ntemi olarak HIFU ile ilgili farkli g venlik sonu larini, kanitlarimizi g lendiren ve hata payimizi d s ren ok b y k bir rneklem b y kl g yle inceleyen literat rdeki ilk ve en kapsamli meta-analizdir. Anahtar Kelimeler: HIFU, ektopik gebelik, endometriozis, gestasyonel trofoblastik hastaliklar, adenomiyoz

Turkish journal of obstetrics and gynecology, 2024-09, Vol.29 (3), p.190

How safe is high-intensity focused ultrasound? An intriguing solution for obstetric and gynecological diseases: A systematic review/Yuksek yogunluklu odaklanmis ultrason ne kadar guvenlidir? Obstetrik ve jinekolojik hastaliklara ilgi cekici bir cozum: Sistematik bir inceleme

High-intensity focused ultrasound (HIFU) is a non-surgical and noninvasive treatment modality that depends on external ultrasound energy sources that induce focused mass ablation and protein degeneration in the treatment area via thermal energy penetration under the intact skin. We aim in our study to collectively evaluate the safety of HIFU for the treatment of different obstetric and gynecological diseases in the literature. We searched PubMed, Scopus, and Science Direct databases, without restriction on date or language, from the inception of these databases until January 20, 2024. We also examined the references of the included studies in the Mendeley archive for eligible articles. We found a total of 706 studies. After the screening and selection process, 56 participants were included. Our dichotomous outcomes were pooled in our single-arm meta-analysis as risk ratio (RR) and with 95% confidence interval (CI) while our continuous outcomes were pooled as mean change and 95% CIs. Fixed- or random-effects models were applied depending on the heterogeneity detected. Our systematic review and meta-analysis included 56 studies including 11.740 patients. Depending on the Society of Interventional Radiology (SIR) classification for adverse effects. The results of this meta-analysis for the type A category that did not require clinical intervention found that pain in the treatment site estimated RR with 95% CI: 0.61 (0.33, 0.89), abnormal vaginal discharge 0.16 (0.073, 0.24), low-grade fever (<38 °C) 0.005 (0.002, 0.009). Sensory abnormalities of the lower limbs were examined in 3390 individuals and observed in only 19 patients who experienced gradual relief of symptoms within one month after treatment. Regarding SIR type B, 99 of a total of 6.437 patients had small vesicles and superficial burns with pooled RR and 95% CI: 0.012 (0.007, 0.018). In terms of groin or perianal and lower abdominal pain, our RRs with 95% CIs were 0.1 (0.067, 0.13) and 0.38 (0.25, 0.51). However, vaginal bleeding was detected in only 32 out of a total of 3.017. Major adverse events like lumber disc herniation, thrombocytopenia, and renal failure, were unmentionable. Additionally, our included studies did not record any deaths. HIFU, either alone or in combination with oxytocin or any other enhancing agent, is safe for patients with different gynecological and obstetric diseases. In terms of efficacy, it showed promising results compared with traditional treatment lines. To our knowledge, we are the first and most comprehensive meta-analysis in the literature that has studied the different safety outcomes related to HIFU as a treatment modality for different obstetric and gynecological diseases with a very large sample size, making our evidence strong and less attributed to errors.

Turkish journal of obstetrics and gynecology, 2024-09, Vol.21 (3), p.190-207

How safe is high-intensity focused ultrasound? An intriguing solution for obstetric and gynecological diseases: A systematic review

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How safe is high-intensity focused ultrasound? An intriguing solution for obstetric and gynecological diseases: A systematic review/Yuksek yogunluklu odaklanmis ultrason ne kadar guvenlidir? Obstetrik...

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How safe is high-intensity focused ultrasound? An intriguing solution for obstetric and gynecological diseases: A systematic review

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