Renal sympathetic nervous system and the effects of denervation on renal arteries

Table 2 Different clinical trials on renal denervation

Trial	Mean followup	Reduction in SBP/DBP	Location	Type	Primary outcome	Safety data
SIMPLICITY I 2009, (n = 50)[35]	6 mo	22/11	Australia/Europe	Catheter-based	Substantial and sustained BP reduction w/o serious adverse events	One case of Renal artery dissection
	12 mo	27/17			Substantial and sustained BP reduction w/o serious adverse events
SIMPLICITY I F/u study 2011[42] (n = 153)	24 mo	32/14	Australia/Europe/United States	Catheter-based	Substantial BP reduction	Groin pseudoaneurysms
SIMPLICITY II 2010, (n = 106)[43]	6 mo	32/12	Australia/Europe/United States	Catheter-based	Meaningful reduction in BP	Hypertensive emergency in 3 cases
Mahfoud 2013, (n = 245)[48]	3 mo	19/13
(n = 236)	6 mo	17/12
(n = 90)	12 mo	16/10	Australia/Germany	Catheter-based	RDN imporved BP relevantly in office and ambulatory scenarios	No adverse events reported
Witowski et al[49]	6 mo	34/13	Poland/United States	Catheter-based	Improvement in severity of sleep apnea, glucose tolerance and BP	No adverse events reported
Brandt et al[75] 2012 (n = 110)	6 mo	29/8	Austria/Germany	Catheter-based	Improves BP, arterial stiffness and central hemodynamics	No adverse events reported
Davies et al[76] 2012, (n = 7)	6 mo	7/0.6	United Kingdom/United States	Catheter-based	Improvement in symptoms and exercise capacity	No adverse events reported
Esler et al[62] 2012 (n = 106)	24 mo	32/12	Australia/Europe/United States	Catheter-based	Saftety and continues benefit with denervation	Hypotension after denervation
Hering et al[64] 2012 (n = 15)	6 mo	32/15	Australia/Europe/United States	Catheter-based	Safe and BP beneficial in resistant HTN and CKD stage 3-4	No peri- or postprocedural complications reported
	12 mo	33/19			Safe and BP beneficial in resistant HTN and CKD stage 3-4
Mahfoud et al[77], 2011	3 mo	28/10	Germany	Catheter-based	Reduction in BP and glycemic control	None reported
Lambert et al[78] 2012, (n = 40)	3 mo	16/6	Australia/Europe	Catheter-based	Quality of life improved after denervation but not directly associated to BP reduction	None reported
Mahfound et al[77] 2011, (n = 37)	1 mo	28/10
	3 mo	32/12	Australia/Germany	Catheter-based	Improvement in glucose levels and insulin sensitivity in addition to BP reduction	No significant adverse events reported
Ott et al[63] 2013, (n = 19)	6 mo	16/7	Germany/United States	Catheter-based	Significantly improvement in peripheral and central BP	No changes in renal function and perfusion
Schlaich et al[61] 2013, (n = 9)	3 mo	18/4	Germany/Australia/Poland/United States	Catheter-based	RDN causes sustained lower BP in ESRD	One patient developed femoral pseudo-aneurysm
(n = 8)	6 mo	16/6
(n = 6)	12 mo	28/5
Steinberg et al[51] 2013, (n = 13)	12 mo	25/10	United States	Catheter-based	RDN patients displayed a significant reduction in systolic and diastolic pressure and maintained	No Adverse events reported
Ukena et al[50] 2012, (n = 2)	6 mo	No Info	Germany/ United States	Catheter-based	Ventricular tachyarrhythmias significantly improved after RDN	No complications reported
Vaclavik et al[79] 2013, (n = 1)	3 mo	No effect in this unilateral procedure	Czech Republic	Catheter-based	Unilateral Renal sympathetic denervation does not lower BP	No complications reported

CKD: Chronic kidney disease.