Long-Term Results up to 12 Months After Catheter-Based Alcohol-Mediated Renal Denervation for Treatment of Resistant Hypertension

Background: Primary results of this prospective, open-label, multicenter trial suggested that alcohol-mediated renal denervation with perivascular injection of dehydrated alcohol using the Peregrine System Infusion Catheter safely reduces blood pressure (BP) in patients with resistant hypertension. To date, maintenance of the BP-lowering effect beyond 6 months using this novel technology has not been reported. This article describes the final, 12-month follow-up data on the safety and efficacy of alcohol-mediated renal denervation in these patients. Methods: Forty-five patients with resistant hypertension on a stable regimen of on average 5.1±1.5 antihypertensive medications underwent successful bilateral renal denervation using the Peregrine Catheter with alcohol as the neurolytic agent (0.6 mL per renal artery). Apart from 2 vascular access pseudoaneurysms (both without sequelae), no major procedural complications occurred. Results: At 12 months post-procedure, mean 24-hour ambulatory systolic and diastolic BP were reduced by 10 mm Hg (95% CI, −16 to −5) and 7 mm Hg (−10 to −3), respectively (P<0.001). Office systolic/diastolic BP was reduced by 20/10 mm Hg (−27, −13/−14, −6; <0.001). Compared with baseline, the number of antihypertensive medications was reduced in 21% of patients, while it was increased in 19%. From baseline to 12 months, serum creatinine, urea, cystatin C, and spot urine albumin levels remained unchanged. The change in estimated glomerular filtration rates (−3.9±10.3 mL/minute per 1.73 m2 [95% CI, −7.1 to −0.75]; P=0.02) was within the expected range. There were no cases of renal artery stenosis up to 12-month follow-up. Conclusions: Catheter-based chemical renal denervation with dehydrated alcohol using the Peregrine Catheter seems to safely reduce BP at follow-up of up to 12 months. Further randomized and sham controlled studies are underway to further validate these findings

Objectifs tensionnels chez l’hypertendu atteint d’une maladie rénale chronique

L’hypertension artérielle est un facteur de risque cardiovasculaire majeur dans le monde. En Belgique, l’insuffisance rénale chronique est principalement d’origine diabétique ou hypertensive. En cas de maladie rénale chronique, le traitement antihypertenseur a pour but de ralentir le déclin de la fonction rénale et de réduire la survenue d’évènements cardiovasculaires. Un objectif tensionnel <140/90-85 mmHg est recommandé chez l’insuffisant rénal chronique, avec un bénéfice additionnel probable à <130/80 mmHg chez les hypertendus présentant une protéinurie pathologique. Il est trop tôt pour juger si l’étude SPRINT va ramener la cible tensionnelle <120/80 mmHg chez ces patients. Que savons-nous à ce propos ? Traiter l’hypertension artérielle permet de réduire la morbi-mortalité cardiovasculaire. Les cibles tensionnelles à atteindre sont influencées par les évidences des grands essais cliniques randomisés contrôlés. Que nous apporte cet article ? Par rapport à des objectifs standards, un contrôle tensionnel plus strict doit démontrer un bénéfice certain en terme de protection cardiovasculaire avant de modifier une recommandation de bonne pratique

Cardiovascular risk assessment in hypertensive patients: major discrepancy according to ESH and SCORE strategies.

BACKGROUND: The European Society of Hypertension (ESH) guidelines recommend two possible strategies for the assessment of cardiovascular risk (CVR) in essential hypertensive (HT) patients: categorical tables and SCORE risk charts. However, the outcome of these methods has not been compared. OBJECTIVE AND METHODS: We assessed CVR according to ESH and SCORE risk charts adapted to use in Belgium in 106 HT patients (mean age: 52.4 +/- 12.9 years, male/female ratio: 46/60) without diabetes or other associated clinical conditions. RESULTS: The distribution of low, moderate, high and very high added risk was strikingly different (kappa coefficient = 0.08) according to ESH categorical tables (n = 1, 24, 24, 57) and SCORE risk charts (n = 60, 12, 10, 24). Furthermore, compared with ESH, CVR class according to SCORE was lower in the majority of patients (n = 72, 68%) while it was similar in 23 (22%) and higher in 11 patients (10%). Patients for whom risk was lower by SCORE compared to ESH differed from the others by age (46.7 +/- 10.0 versus 64.6 +/- 9.2, P < 10) and proportion of females (71 versus 26%, P < 10). CONCLUSIONS: In this series of patients with mainly moderate or severe hypertension, the distribution of cardiovascular risk was strikingly different according to ESH categorical tables and SCORE risk charts. This might be explained in part by the lower weight attributed to blood pressure in risk assessment, especially in young female subjects. If confirmed, these results should prompt the performance of a prospective study to assess which strategy most accurately predicts CVR in hypertensive patients

Cardiovascular risk assessment in hypertensive patients: major discrepancy according to ESH and SCORE strategies.

BACKGROUND: The European Society of Hypertension (ESH) guidelines recommend two possible strategies for the assessment of cardiovascular risk (CVR) in essential hypertensive (HT) patients: categorical tables and SCORE risk charts. However, the outcome of these methods has not been compared. OBJECTIVE AND METHODS: We assessed CVR according to ESH and SCORE risk charts adapted to use in Belgium in 106 HT patients (mean age: 52.4 +/- 12.9 years, male/female ratio: 46/60) without diabetes or other associated clinical conditions. RESULTS: The distribution of low, moderate, high and very high added risk was strikingly different (kappa coefficient = 0.08) according to ESH categorical tables (n = 1, 24, 24, 57) and SCORE risk charts (n = 60, 12, 10, 24). Furthermore, compared with ESH, CVR class according to SCORE was lower in the majority of patients (n = 72, 68%) while it was similar in 23 (22%) and higher in 11 patients (10%). Patients for whom risk was lower by SCORE compared to ESH differed from the others by age (46.7 +/- 10.0 versus 64.6 +/- 9.2, P < 10) and proportion of females (71 versus 26%, P < 10). CONCLUSIONS: In this series of patients with mainly moderate or severe hypertension, the distribution of cardiovascular risk was strikingly different according to ESH categorical tables and SCORE risk charts. This might be explained in part by the lower weight attributed to blood pressure in risk assessment, especially in young female subjects. If confirmed, these results should prompt the performance of a prospective study to assess which strategy most accurately predicts CVR in hypertensive patients