Adverse Events
Just one of the researches included in this review did not use AE as an
endpoint parameter13. 124 of 1360 patients (9.1%) had
an adverse reaction to one of the 1360 therapies studied. During the
follow-up period, 120 AEs were minor and self-limiting. Just two
patients (0.3%) had a severe adverse effect (SAE), one of which was a
deep venous thrombosis (DVT), and the other was a third-degree skin
burn. Two of the most recent studies listed these SAEs (patient
enrollment between 2005 and 2009)24,39. Sonalleve and
ExAblate had a significant gap of (S) AE stratification, 18.4 percent,
and 6.7 percent, respectively. Meta-regression verified that the
difference between Sonalleve and ExAblate was statistically significant
(p <0.05). None of the other covariates studied (NPV percent,
sonication time) was linked to adverse outcomes. However, not many
serious adverse events were reported in the study.
However, a follow-up MRI is expensive and not required. Similarly,
re-interventions were found in two studies that showed reintervention
needed in 18-24% of patients.