Adverse effect analysis of high-intensity focused ultrasound in the treatment of benign uterine diseases

Figures & data

Table 1. Baseline characteristics of patients with uterine benign diseases treated with HIFU.

Variables	Data
Number of patients	27,053
Age (years)	42 (37–45)
Height (cm)	158 (155–160)
Weight (kg)	56 (51–61)
BMI (kg/cm^2)	22.5 (20.7–24.6)
Number of patients with uterine fibroids (solitary/multiple)	12,342/5060
Number of patients with adenomyosis (focal/diffuse)	7020/1414
Number of patients with cesarean scar pregnancy	876
Number of patients with placenta accreta	341

Data are numbers and median value (interquartile range).

BMI: body mass index.

Table 2. Treatment results of HIFU for patients with uterine benign diseases.

Variables	Uterine fibroids	Adenomyosis	Cesarean scar pregnancy	Placenta accreta
Sonication power (W)	400 (394–400)	399 (384–400)	400 (399–400)	400 (399–400)
Treatment time (min)	72 (45–109)	70 (47–104)	53 (36–74)	72 (49–103)
Sonication time (s)	607 (350–1001)	580 (350–950)	400 (281–600)	701 (441–1085)
Sonication time per hour (s/h)	537 (438–650)	509 (420–617)	486 (411–560)	585 (500–688)
Total energy used (kJ)	240 (138–400)	222 (131–376)	160 (104–231)	280 (175–434)
NPV ratio	85% (75–94%)	72% (57–85%)	–	–

Data are expressed as median value (interquartile range).

NPV: Non-perfused volume.

Table 3. Society of interventional radiology classification of adverse effects after HIFU treatment.

SIR classification	Adverse effects	Number of events	Incidence rate (%)
Class A	Mild lower abdominal pain	8263	30.5437
	Sacrococcygeal pain	2833	10.4720
	Abnormal vaginal discharge	1270	4.6945
	Lower limb paresthesia	188	0.6949
	Nausea and vomiting	108	0.3992
	Erythema on skin	86	0.3179
	Fever	79	0.2920
	Hematuria	24	0.0887
Total	–	12,851	47.5030
Class B	Lower abdominal pain	113	0.4177
	Sacrococcygeal pain	33	0.1220
	Abnormal vaginal discharge	27	0.0998
	Skin blisters	20	0.0739
	Lower limb paresthesia	19	0.0702
	Fever	3	0.0111
Total	–	215	0.7947
Class C	Skin burns	38	0.1405
	Leg pain	17	0.0628
	Vaginal discharge or bleeding	13	0.0481
	Urinary retention	8	0.0296
	Hyperpyrexia	7	0.0259
	Acute cystitis	4	0.0148
	Intrauterine infection	3	0.0111
Total	–	90	0.3327
Class D	Bowel injury	4	0.0148
	Acute renal failure	4	0.0148
	Deep vein thrombosis	2	0.0074
	Pubic symphysis injury	1	0.0037
	Post-HIFU thrombocytopenia	1	0.0037
	Sciatic nerve injury	1	0.0037
	Hydronephrosis	1	0.0037
Total	–	14	0.0518
Class E&F	–	0	0.0000

Figure 1. Annual rate of major adverse effects of patients with benign uterine diseases treated with HIFU.

Table 4. Comparison in incidence of major complications after HIFU treatment among patients with uterine fibroids, adenomyosis and placenta accreta.

	Uterine fibroids (%)	Adenomyosis (%)	Placenta accreta (%)	p
Skin burns	0.1494	0.1304	0.2933	.718
Leg pain	0.0575	0.0830	–	.672
Urinary retention	0.0402	0.0119	–	.506
Vaginal bleeding	0.0345	0.0830	–	.272
Hyperpyrexia	0.0287	0.0119	0.2933	.066
Renal failure	0.0230	–	–	.346
Acute cystitis	0.0172	0.0119	–	1.000
Bowel injury	0.0172	0.0119	–	1.000
Intrauterine infection	0.0115	0.0119	–	1.000
Deep vein thrombosis	0.0115	–	–	1.000
Hydronephrosis	0.0057	–	–	1.000
Pubic symphysis injury	0.0057	–	–	1.000
Thrombocytopenia	0.0057	–	–	1.000
Sciatic nerve injury	–	0.0119	–	.335
Total	0.4080	0.3676	0.5865	–