Catheter-Based Renal Sympathetic Denervation for Resistant Hypertension Durability of Blood Pressure Reduction Out to 24 Months

Renal sympathetic hyperactivity is seminal in the maintenance and progression of hypertension. Catheter-based renal sympathetic denervation has been shown to significantly reduce blood pressure (BP) in patients with hypertension. Durability of effect beyond 1 year using this novel technique has never been reported. A cohort of 45 patients with resistant hypertension (systolic BP GT = 160 mm Hg on GT = 3 antihypertension drugs, including a diuretic) has been originally published. Herein, we report longer-term follow-up data on these and a larger group of similar patients subsequently treated with catheter-based renal denervation in a nonrandomized manner. We treated 153 patients with catheter-based renal sympathetic denervation at 19 centers in Australia, Europe, and the United States. Mean age was 57 +/- 11 years, 39% were women, 31% were diabetic, and 22% had coronary artery disease. Baseline values included mean office BP of 176/98 +/- 17/15 mm Hg, mean of 5 antihypertension medications, and an estimated glomerular filtration rate of 83 +/- 20 mL/min per 1.73 m(2). The median time from first to last radiofrequency energy ablation was 38 minutes. The procedure was without complication in 97% of patients (149 of 153). The 4 acute procedural complications included 3 groin pseudoaneurysms and 1 renal artery dissection, all managed without further sequelae. Postprocedure office BPs were reduced by 20/10, 24/11, 25/11, 23/11, 26/14, and 32/14 mm Hg at 1, 3, 6, 12, 18, and 24 months, respectively. In conclusion, in patients with resistant hypertension, catheter-based renal sympathetic denervation results in a substantial reduction in BP sustained out to GT = 2 years of follow-up, without significant adverse events. (Hypertension. 2011;57:911-917.

Status Update and Interim Results from the Asymptomatic Carotid Surgery Trial-2 (ACST-2)

Objectives: ACST-2 is currently the largest trial ever conducted to compare carotid artery stenting (CAS) with carotid endarterectomy (CEA) in patients with severe asymptomatic carotid stenosis requiring revascularization. Methods: Patients are entered into ACST-2 when revascularization is felt to be clearly indicated, when CEA and CAS are both possible, but where there is substantial uncertainty as to which is most appropriate. Trial surgeons and interventionalists are expected to use their usual techniques and CE-approved devices. We report baseline characteristics and blinded combined interim results for 30-day mortality and major morbidity for 986 patients in the ongoing trial up to September 2012. Results: A total of 986 patients (687 men, 299 women), mean age 68.7 years (SD ± 8.1) were randomized equally to CEA or CAS. Most (96%) had ipsilateral stenosis of 70-99% (median 80%) with contralateral stenoses of 50-99% in 30% and contralateral occlusion in 8%. Patients were on appropriate medical treatment. For 691 patients undergoing intervention with at least 1-month follow-up and Rankin scoring at 6 months for any stroke, the overall serious cardiovascular event rate of periprocedural (within 30 days) disabling stroke, fatal myocardial infarction, and death at 30 days was 1.0%. Conclusions: Early ACST-2 results suggest contemporary carotid intervention for asymptomatic stenosis has a low risk of serious morbidity and mortality, on par with other recent trials. The trial continues to recruit, to monitor periprocedural events and all types of stroke, aiming to randomize up to 5,000 patients to determine any differential outcomes between interventions. Clinical trial: ISRCTN21144362. © 2013 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved

Second asymptomatic carotid surgery trial (ACST-2): a randomised comparison of carotid artery stenting versus carotid endarterectomy

Background: Among asymptomatic patients with severe carotid artery stenosis but no recent stroke or transient cerebral ischaemia, either carotid artery stenting (CAS) or carotid endarterectomy (CEA) can restore patency and reduce long-term stroke risks. However, from recent national registry data, each option causes about 1% procedural risk of disabling stroke or death. Comparison of their long-term protective effects requires large-scale randomised evidence. Methods: ACST-2 is an international multicentre randomised trial of CAS versus CEA among asymptomatic patients with severe stenosis thought to require intervention, interpreted with all other relevant trials. Patients were eligible if they had severe unilateral or bilateral carotid artery stenosis and both doctor and patient agreed that a carotid procedure should be undertaken, but they were substantially uncertain which one to choose. Patients were randomly allocated to CAS or CEA and followed up at 1 month and then annually, for a mean 5 years. Procedural events were those within 30 days of the intervention. Intention-to-treat analyses are provided. Analyses including procedural hazards use tabular methods. Analyses and meta-analyses of non-procedural strokes use Kaplan-Meier and log-rank methods. The trial is registered with the ISRCTN registry, ISRCTN21144362. Findings: Between Jan 15, 2008, and Dec 31, 2020, 3625 patients in 130 centres were randomly allocated, 1811 to CAS and 1814 to CEA, with good compliance, good medical therapy and a mean 5 years of follow-up. Overall, 1% had disabling stroke or death procedurally (15 allocated to CAS and 18 to CEA) and 2% had non-disabling procedural stroke (48 allocated to CAS and 29 to CEA). Kaplan-Meier estimates of 5-year non-procedural stroke were 2·5% in each group for fatal or disabling stroke, and 5·3% with CAS versus 4·5% with CEA for any stroke (rate ratio [RR] 1·16, 95% CI 0·86–1·57; p=0·33). Combining RRs for any non-procedural stroke in all CAS versus CEA trials, the RR was similar in symptomatic and asymptomatic patients (overall RR 1·11, 95% CI 0·91–1·32; p=0·21). Interpretation: Serious complications are similarly uncommon after competent CAS and CEA, and the long-term effects of these two carotid artery procedures on fatal or disabling stroke are comparable. Funding: UK Medical Research Council and Health Technology Assessment Programme

Endovascular treatment of symptomatic high-grade vertebral artery stenosis

BACKGROUND The purpose of this study was to evaluate the initial and long-term results of endovascular treatment (EVT) in patients with symptomatic high-grade extracranial vertebral artery (VA) origin stenosis. METHODS From February 2001 to March 2013, 73 consecutive patients (33 men with a mean age of 61.7 ± 8.8 years) underwent EVT for symptomatic high-grade VA stenosis. Preoperative evaluation included Duplex ultrasonography and arteriography. After successful treatment, all patients were followed up at 1, 3, 6, and 12 months after the procedure and every 6 months thereafter. RESULTS Successful EVT of the VA stenosis was achieved in 68 patients (93.2%). All procedures were performed without use of cerebral protection. The early complication rate was 5.5%, which included one periprocedural transient ischemic attack, two hematomas at the puncture site, and one allergic reaction to the contrast agent. No in-hospital deaths occurred. During follow-up (mean, 44.3 ± 31.2 months; range, 2-144 months), the primary patency rates at 1, 3, 5, and 7 years were 98.4%, 87.3%, 87.3%, and 87.3%, respectively. Ultrasound Doppler controls during follow-up detected seven VA restenoses (10.3%). Univariate analysis failed to identify any variable predictive of long-term patency of successfully treated VA stenosis. CONCLUSIONS EVT of symptomatic VA origin stenosis is a safe and effective procedure associated with low risk and good long-term results, even without use of cerebral protection devices

Correlation of Color Doppler with Multidetector CT Angiography Findings in Carotid Artery Stenosis

The aim of this paper was to examine the correlation between the Color Doppler ultrasound (CD-US) and multidetector CT angiography (MDCTA) diagnostic methods, and to define the degree and extent of stenosis in patients with internal carotid artery stenosis. This was a cross-sectional study with a consecutive series of patients. All US examinations were always carried out by the same physician-angiologist, while all CT examinations were always carried out by the same physician-radiologist. Both worked independently from each other. The stenosis area was measured at the narrowest point by NASCET criteria for US/CT. Peak systolic velocity (PSV) over 210 cm/sec and end diastolic velocity (EDV) over 110 cm/sec criteria were applied for stenoses with lumen narrowed over 70%, while PSV under 130 cm/sec and EDV under 100 cm/sec criteria were applied for those with lumen narrowed under 70%. A total of 124 carotid arteries were observed; namely, 89 narrowed and 68 surgically treated. All patients were reviewed by US and then by MDCTA; patients with 70–99% stenosis underwent surgery. The correlation coefficient between stenosis degree measured by US and MDCTA was 0.922; p < 0.01. The average difference between US and MDCTA diagnostic methods was 3% (Z = -1.438, p > 0.05). The US and CT matching level for stenoses from 70 to 99% was very high (κ = 0.778, p < 0.01). In conclusion, there is a highly significant statistical correlation among both diagnostic methods when measuring stenosis degree and extent. US is more dependent on the physician, while MDCTA is more objective and independent from the physician. We think it would be appropriate to undertake an MDCTA exam for those patients who are candidates for carotid endarterectomy