Supplementary Table 7.
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.