Impact of multi-electrode renal sympathetic denervation on short-term blood pressure variability in patients with drug-resistant hypertension. Insights from the EnligHTN I study.

Transluminal renal sympathetic denervation (RDN) has been shown to reduce blood pressure (BP) in patients with treatment-resistant hypertension. We assessed the effect of multi-electrode RDN on short-term BP variability indexes in resistant hypertensives. Thirty-one patients with drug-resistant uncontrolled hypertension, participants in the EnligHTN I study, underwent ambulatory BP measurements at baseline and 6months after RDN using the EnligHTN ablation catheter (St. Jude Medical). Twelve resistant hypertensives matched for office BP served as control group. At 6months post-RDN, office BP and 24-hour BP were reduced by 25.6/10.3mmHg and by 10.2/6mmHg (p<0.001 for all cases), respectively. No significant changes were observed 6months post-RDN in standard short-term BP variability indexes including 24-hour systolic and diastolic average real variability. The rates of systolic and diastolic 24-hour BP variation were decreased 6months after RDN, (from 0.40/0.30 to 0.34/0.24, p=0.030/0.006, respectively), especially in the responders group (n=23, 74.2%). No significant differences in BP and BP variability parameters in the control group were detected. ROC analysis revealed an area under the curve for prediction of response to RDN by systolic time rate of 66.8% (95% CI: 46.7% to 87%; p=0.16) and by diastolic time rate of 76.1% (95% CI: 58.2% to 93.9%; p=0.030). Although standard BP variability indexes remained unchanged, the rate of systolic and diastolic BP variation was significantly decreased 6months after RDN in patients with drug-resistant hypertension. These novel indexes might also be useful as predictors of response.

Tsioufis C ，Papademetriou V ，Tsiachris D ，Kasiakogias A ，Kordalis A ，Thomopoulos C ，Dimitriadis K ，Tousoulis D ，Stefanadis C ，Parati G ，Worthley S ... -  《-》

Individual-patient visit-by-visit office and ambulatory blood pressure measurements over 24months in patients undergoing renal denervation for hypertension.

Renal denervation (RDN) is a promising treatment option in addition to medical antihypertensive treatment in patients suffering from resistant hypertension. Despite the growing interest in RDN, only few long-term results are published so far. We systematically investigated the effects of RDN on ABPM in a consecutive series of patients with resistant hypertension out to 24 months. Office BP measurements and ABPM assessment were offered at 3, 6, 12 and 24 months. The patients with an average systolic BP reduction of more than 10 mmHg in office BP 6months after RDN were classified as responders. Additional to this classical responder concept, we categorized response to RDN by an individual-patient visit-by-visit evaluation of office BP and 24-hour-BP, separately. We included 32 patients. In 21 patients (65.6%) we found a mean systolic BP reduction >10 mmHg in office BP six months after RDN. These patients were classified as responders. In responders, mean office BP dropped from 175.3 ± 15.9/96 ± 14.2 mmHg to 164.8 ± 24.4/93.2 ± 10.4 mmHg (p=0.040/p=0.323) and mean 24-h BP in ABPM decreased from 146.8 ± 17.0/89.1 ± 11 mmHg to 136.8 ± 15.0/83.2 ± 10.7 mmHg after 24 months (p=0.034/p=0.014). Additionally, we performed a visit-by-visit evaluation of all patients and results were divided in larger-than-median and smaller-than-median response. By this evaluation, we found a high variation of office BP reductions and the 24-hour BP results demonstrated a significant BP reduction in patients with larger-than-median response, which sustained over the 24 months of follow-up. In contrast to the observed variation of office BP measurements, ABPM demonstrated a reproducible and sustained significant BP reduction in patients with larger-than-median response to RDN.

Lambert T ，Gammer V ，Nahler A ，Blessberger H ，Kammler J ，Grund M ，Kerschner K ，Buchmayr G ，Saleh K ，Kypta A ，Hönig S ，Wichert-Schmitt B ，Schwarz S ，Sihorsch K ，Reiter C ，Steinwender C ... -  《-》

Catheter-based renal denervation for resistant hypertension: Twenty-four month results of the EnligHTN I first-in-human study using a multi-electrode ablation system.

Long term safety and efficacy data of multi-electrode ablation system for renal denervation (RDN) in patients with drug resistant hypertension (dRHT) are limited. We studied 46 patients (age: 60 ± 10 years, 4.7 ± 1.0 antihypertensive drugs) with drug resistant hypertension (dRHT). Reduction in office BP at 24 months from baseline was -29/-13 mmHg, while the reduction in 24-hour ambulatory BP and in home BP at 24 months were -13/-7 mmHg and -11/-6 mmHg respectively (p<0.05 for all). A correlation analysis revealed that baseline office and ambulatory BP were related to the extent of office and ambulatory BP drop. Apart from higher body mass index (33.3 ± 4.7 vs 29.5 ± 6.2 kg/m(2), p<0.05), there were no differences in patients that were RDN responders defined as ≥10 mmHg decrease (74%, n=34) compared to non-responders. Stepwise logistic regression analysis revealed no prognosticators of RDN response (p=NS for all). At 24 months there were no new serious device or procedure related adverse events. The EnligHTN I study shows that the multi-electrode ablation system provides a safe method of RDN in dRHT accompanied by a clinically relevant and sustained BP reduction.

Tsioufis CP ，Papademetriou V ，Dimitriadis KS ，Kasiakogias A ，Tsiachris D ，Worthley MI ，Sinhal AR ，Chew DP ，Meredith IT ，Malaiapan Y ，Thomopoulos C ，Kallikazaros I ，Tousoulis D ，Worthley SG ... -  《-》

Ambulatory blood pressure changes after renal sympathetic denervation in patients with resistant hypertension.

Mahfoud F ，Ukena C ，Schmieder RE ，Cremers B ，Rump LC ，Vonend O ，Weil J ，Schmidt M ，Hoppe UC ，Zeller T ，Bauer A ，Ott C ，Blessing E ，Sobotka PA ，Krum H ，Schlaich M ，Esler M ，Böhm M ... -  《-》

Substantial reduction in single sympathetic nerve firing after renal denervation in patients with resistant hypertension.

Hering D ，Lambert EA ，Marusic P ，Walton AS ，Krum H ，Lambert GW ，Esler MD ，Schlaich MP ... -  《-》