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. 2017 Jul 5;130(13):1586–1594. doi: 10.4103/0366-6999.208238

Supplementary Table 7.

The adverse effect of RDN reported by included studies

Clinical trails Adverse effect of RDN
DENERHTN Lumbar pain in two patients and mild groin hematoma in one patient
DENERVHTA Mild groin hematoma (n = 3) and transient symptomatic hypotension (n = 3)
OSLO One patient in the RDN group had a myocardial infarction 5 months after the procedure. Four patients had mild-to-moderate hematomas at the femoral access site for RDN. One patient had bradycardia and received atropin injection during RDN. Four patients in the drug-adjusted group and one patient in the RDN group had symptomatic hypotension. Two patients experience sexual dysfunction after increasing the dosage of spironolactone in the drug-adjusted group
Prague-15 Spasms after application of radiofrequency energy, four patients
Dissection of renal artery, one patient
Postpunctual pseudoaneurysm, two patients
Arteriovenous fistula, one patient
Laryngospasm after analgosedation, one patient
Asymptomatic bradycardia after procedure, two patients
Phlebitis associated with peripheral line, one patient
ReSET Femoral hematoma
SYMPLICITYHTN-2 There were no serious complications related to the device or procedure. Minor periprocedural events included one femoral artery pseudoaneurysm, one post-procedure hypotension, one urinary tract infection and one case of back pain. Seven patients had transient intraprocedural bradycardia requiring atropine. Renal function was unchanged at 6 months. There were 5 hypertensive emergencies three patients in RDN group and 2 in control group. Other events requiring admission included one case of nausea and edema, one hypertensive crisis, one TIA, one hypotensive episode, and one coronary stent for angina
SYMPLICITYHTN-3 Major adverse events: 5/361 versus 1/171
Composite safety endpoint at 6 months: 14/354 versus 10/171
Death: 2/352 versus 1/171
Myocardial infarction 6/352 versus 3/171
Increase in serum creatinine of >50% from baseline 5/352 versus 1/171
Embolic event resulting in end-organ damage: 1/352 versus 0/171
Vascular complication requiring treatment: 1/352 versus 0/171
Hypertensive crisis or emergency: 9/352 versus 9/171
Stroke: 4/352 versus 2/171
Hospitalization for new-onset heart failure: 9/352 versus 3/171
Hospitalization for atrial fibrillation: 5/352 versus 1/171
New renal-artery stenosis of >70% 1/332 versus 0/165
SYMPLICITY HTN-Japan No major adverse events were reported
SYMPLICITY-FLEX There were no deaths, other serious adverse events, or vascular complications

RDN: Renal denervation; TIA: Transient ischemic attack.