Endovascular Ultrasound Renal Denervation to Treat Hypertension: The RADIANCE II Randomized Clinical Trial.

Importance: Two initial sham-controlled trials demonstrated that ultrasound renal denervation decreases blood pressure (BP) in patients with mild to moderate hypertension and hypertension that is resistant to treatment. Objective: To study the efficacy and safety of ultrasound renal denervation without the confounding influence of antihypertensive medications in patients with hypertension. Design, Setting, and Participants: Sham-controlled, randomized clinical trial with patients and outcome assessors blinded to treatment assignment that was conducted between January 14, 2019, and March 25, 2022, at 37 centers in the US and 24 centers in Europe, with randomization stratified by center. Patients aged 18 years to 75 years with hypertension (seated office systolic BP [SBP] ≥140 mm Hg and diastolic BP [DBP] ≥90 mm Hg despite taking up to 2 antihypertensive medications) were eligible if they had an ambulatory SBP/DBP of 135/85 mm Hg or greater and an SBP/DBP less than 170/105 mm Hg after a 4-week washout of their medications. Patients with an estimated glomerular filtration rate of 40 mL/min/1.73 m2 or greater and with suitable renal artery anatomy were randomized 2:1 to undergo ultrasound renal denervation or a sham procedure. Patients were to abstain from antihypertensive medications until the 2-month follow-up unless prespecified BP criteria were exceeded and were associated with clinical symptoms. Interventions: Ultrasound renal denervation vs a sham procedure. Main Outcomes and Measures: The primary efficacy outcome was the mean change in daytime ambulatory SBP at 2 months. The primary safety composite outcome of major adverse events included death, kidney failure, and major embolic, vascular, cardiovascular, cerebrovascular, and hypertensive events at 30 days and renal artery stenosis greater than 70% detected at 6 months. The secondary outcomes included mean change in 24-hour ambulatory SBP, home SBP, office SBP, and all DBP parameters at 2 months. Results: Among 1038 eligible patients, 150 were randomized to ultrasound renal denervation and 74 to a sham procedure (mean age, 55 years [SD, 9.3 years]; 28.6% female; and 16.1% self-identified as Black or African American). The reduction in daytime ambulatory SBP was greater with ultrasound renal denervation (mean, -7.9 mm Hg [SD, 11.6 mm Hg]) vs the sham procedure (mean, -1.8 mm Hg [SD, 9.5 mm Hg]) (baseline-adjusted between-group difference, -6.3 mm Hg [95% CI, -9.3 to -3.2 mm Hg], P < .001), with a consistent effect of ultrasound renal denervation throughout the 24-hour circadian cycle. Among 7 secondary BP outcomes, 6 were significantly improved with ultrasound renal denervation vs the sham procedure. No major adverse events were reported in either group. Conclusions and Relevance: In patients with hypertension, ultrasound renal denervation reduced daytime ambulatory SBP at 2 months in the absence of antihypertensive medications vs a sham procedure without postprocedural major adverse events. Trial Registration: ClinicalTrials.gov Identifier: NCT03614260.

Renal Artery Variations in Patients With Mild-to-Moderate Hypertension From the RADIANCE-HTN SOLO Trial.

PURPOSE: To assess the variability of renal artery (RA) anatomy and presence of RA-pathology in patients with mild-to-moderate hypertension enrolled in the RADIANCE-HTN SOLO trial. BACKGROUND: RADIANCE-HTN SOLO was a multicenter, international, blinded, randomized, sham-controlled trial evaluating ultrasound-based endovascular renal denervation (RDN) in patients with mild-to-moderate hypertension while off antihypertensive medications. METHODS: Eligible subjects had pre-randomization renal CT- or MR- angiography (CTA, MRA) to confirm anatomic suitability and to define RA ablation sites. All images were sent for independent review for evaluation of RA anatomy and other vascular pathology. RESULTS: A total of 324 patients underwent RA imaging (282 CTA and 42 MRA). Of those, 178 had simple anatomy with a single left and single right RA with mean diameters of 5.4 ± 0.9 and 5.1 ± 0.8 mm and mean lengths of 40.0 ± 12.9 and 52.0 ± 13.1 mm, respectively. Twenty-seven patients (8.3%) had unilateral or bilateral dual RAs with mean diameters of 4.0 ± 0.9 mm on the left and 3.9 ± 0.9 mm on the right. Forty percent (129/324) of patients had at least 1 accessory RA, with mean accessory diameters of 2.4 ± 0.8 mm on the left and 2.3 ± 0.8 mm on the right. Twenty-eight patients (8.6%) had at least 1 short (<25 mm) main RA. Incidental findings included: 9 patients (2.8%) with atherosclerotic RA stenosis ≥30%, 9 patients (2.8%) with fibromuscular dysplasia of RA and 2 patients (0.6%) with kidney and adrenal gland tumors. CONCLUSIONS: Pre-procedure CTA or MRA imaging is a valuable aid in assessing RA anatomy prior to RDN because of variable RA anatomy. CTA or MRA may detect RA lesions, and renal or adrenal tumors which may need additional workup prior to consideration of RDN. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov NCT02649426.

Ultrasound renal denervation for hypertension resistant to a triple medication pill (RADIANCE-HTN TRIO): a randomised, multicentre, single-blind, sham-controlled trial.

BACKGROUND: Endovascular renal denervation reduces blood pressure in patients with mild-to-moderate hypertension, but its efficacy in patients with true resistant hypertension has not been shown. We aimed to assess the efficacy and safety of endovascular ultrasound renal denervation in patients with hypertension resistant to three or more antihypertensive medications. METHODS: In a randomised, international, multicentre, single-blind, sham-controlled trial done at 28 tertiary centres in the USA and 25 in Europe, we included patients aged 18-75 years with office blood pressure of at least 140/90 mm Hg despite three or more antihypertensive medications including a diuretic. Eligible patients were switched to a once daily, fixed-dose, single-pill combination of a calcium channel blocker, an angiotensin receptor blocker, and a thiazide diuretic. After 4 weeks of standardised therapy, patients with daytime ambulatory blood pressure of at least 135/85 mm Hg were randomly assigned (1:1) by computer (stratified by centres) to ultrasound renal denervation or a sham procedure. Patients and outcome assessors were masked to randomisation. Addition of antihypertensive medications was allowed if specified blood pressure thresholds were exceeded. The primary endpoint was the change in daytime ambulatory systolic blood pressure at 2 months in the intention-to-treat population. Safety was also assessed in the intention-to-treat population. This study is registered with ClinicalTrials.gov, NCT02649426. FINDINGS: Between March 11, 2016, and March 13, 2020, 989 participants were enrolled and 136 were randomly assigned to renal denervation (n=69) or a sham procedure (n=67). Full adherence to the combination medications at 2 months among patients with urine samples was similar in both groups (42 [82%] of 51 in the renal denervation group vs 47 [82%] of 57 in the sham procedure group; p=0·99). Renal denervation reduced daytime ambulatory systolic blood pressure more than the sham procedure (-8·0 mm Hg [IQR -16·4 to 0·0] vs -3·0 mm Hg [-10·3 to 1·8]; median between-group difference -4·5 mm Hg [95% CI -8·5 to -0·3]; adjusted p=0·022); the median between-group difference was -5·8 mm Hg (95% CI -9·7 to -1·6; adjusted p=0·0051) among patients with complete ambulatory blood pressure data. There were no differences in safety outcomes between the two groups. INTERPRETATION: Compared with a sham procedure, ultrasound renal denervation reduced blood pressure at 2 months in patients with hypertension resistant to a standardised triple combination pill. If the blood pressure lowering effect and safety of renal denervation are maintained in the long term, renal denervation might be an alternative to the addition of further antihypertensive medications in patients with resistant hypertension. FUNDING: ReCor Medical.

Transradial Repair of Type IA Endoleak.

An 81-year-old Caucasian male with a known abdominal aortic aneurysm (AAA) was referred to the endovascular clinic. One month after successful endovascular repair, surveillance CTA showed endoleak with presence of contrast within the aneurysmal sac. An elective repair was performed.

Randomized Comparison of a CrossBoss First Versus Standard Wire Escalation Strategy for Crossing Coronary Chronic Total Occlusions: The CrossBoss First Trial.

OBJECTIVES: The authors performed a multicenter, randomized-controlled, clinical trial comparing upfront use of the CrossBoss catheter versus antegrade wire escalation for antegrade crossing of coronary chronic total occlusions. BACKGROUND: There is equipoise about the optimal initial strategy for crossing coronary chronic total occlusions. METHODS: The primary endpoints were the time required to cross the chronic total occlusion or abort the procedure and the frequency of procedural major adverse cardiovascular events. The secondary endpoints were technical and procedural success, total procedure time, fluoroscopy time required to cross and total fluoroscopy time, total air kerma radiation dose, total contrast volume, and equipment use. RESULTS: Between 2015 and 2017, 246 patients were randomized to the CrossBoss catheter (n = 122) or wire escalation (n = 124) at 11 U.S. centers. The baseline clinical and angiographic characteristics of the study groups were similar. Technical and procedural success were 87.8% and 84.1%, respectively, and were similar in the 2 groups. Crossing time was similar: 56 min (interquartile range: 33 to 93 min) in the CrossBoss group and 66 min (interquartile range: 36 to 105 min) in the wire escalation group (p = 0.323), as was as the incidence of procedural major adverse cardiovascular events (3.28% vs. 4.03%; p = 1.000). There were no significant differences in the secondary study endpoints. CONCLUSIONS: As compared with wire escalation, upfront use of the CrossBoss catheter for antegrade crossing of coronary chronic total occlusions was associated with similar crossing time, similar success and complication rates, and similar equipment use and cost.

Acute coronary thrombosis and multiple coronary aneurysms in a 22-year-old man with the human immunodeficiency virus.

The human immunodeficiency virus (HIV) can cause diverse cardiovascular complications. In HIV patients on antiretroviral therapy, the prevalence of myocardial infarction has steadily increased over the years. Young patients who are naïve to antiretroviral therapy and who experience coronary events are not well represented in the medical literature. We describe the case of a 22-year-old man, infected with HIV for 4 years and never treated with antiretroviral therapy, who emergently presented with a non-ST-segment-elevation myocardial infarction. Coronary angiograms revealed thrombosis and multiple coronary artery aneurysms; however, no areas of atherosclerotic stenosis were apparent. He was successfully treated with coronary stenting, antiplatelet therapy, and anticoagulation. Nine months after the initial presentation, he exhibited excellent exercise capacity, and no ischemia was evident. We discuss the various therapeutic approaches in this case.

Histopathologic changes of the radial artery wall secondary to transradial catheterization.

OBJECTIVE: The immediate effects of transradial access on the radial artery wall are unknown. In this study we sought to assess the histological changes induced by catheterization on the radial artery. METHODS: Thirty-four patients undergoing coronary artery bypass grafting (CABG) had radial arteries harvested to serve as bypass conduits. The proximal and distal ends of the radial artery conduits were sectioned and embedded in paraffin. Both ends of all specimens were evaluated by a blinded pathologist for intimal hyperplasia, medial inflammation, medial calcification, periarterial tissue or fat necrosis, adventitial inflammation, adventitial necrosis, and adventitial neovascularization. Fisher's exact test was used for statistical analysis. RESULTS: Fifteen previously catheterized radial arteries (TRA group) were compared with 19 noncatheterized arteries (NCA group). The distal ends of the TRA group showed significantly more intimal hyperplasia (73.3% vs 21.1%; p = 0.03), periarterial tissue or fat necrosis (26% vs 0%; p = 0.02), and more adventitial inflammation (33.3% vs 0%; p = 0.01) than the distal ends of the NCA group. The distal ends of the TRA group also showed significantly more intimal hyperplasia (73.3% vs 26.6%; p = 0.03) and adventitial inflammation (33.3% vs 0%; p = 0.01) than the proximal ends of the same arteries. There were no histological differences in the proximal ends of the two groups. CONCLUSION: Transradial catheterization induces significant histological changes suggestive of radial artery injury limited to the puncture site in the form of intimal hyperplasia, medial inflammation, and tissue necrosis. Both the proximal and distal ends of the radial artery show a spectrum of atherosclerotic changes independent of its use for transradial catheterization.

Nitroglycerin, nitroprusside, or both, in preventing radial artery spasm during transradial artery catheterization.

OBJECTIVE: Radial artery spasm remains a major complication of transradial coronary interventions. The aim of this study was to compare the efficacy of three different intra-arterial vasodilating cocktails in reducing the incidence of radial artery spasm in patients undergoing transradial coronary angiography. The secondary goal was to assess the predictors of arterial spasm in this large group of patients. METHODS: A total of 379 patients undergoing the procedure were randomly enrolled in 1 of 3 groups. Every patient in each of the 3 groups received intra-arterial heparin, lidocaine and diltiazem. Along with that, patients in Group A received nitroglycerin; patients in Group B received nitroprusside instead of nitroglycerin; and patients in Group C received both nitroglycerin and nitroprusside. A single experienced operator, blinded to the study drug, subjectively determined the presence of spasm. RESULTS: Of 379 patients, a total of 44 patients (11.6%) experienced spasm. The occurrence of spasm was similar, independent of the vasodilator cocktail used (Group A: 12.2%, Group B: 13.4%, Group C: 9.5%; p = 0.597). After multivariate analysis, the following variables were found to be independent predictors of spasm: radial artery diameter (RD)/height index (p = 0.005), RD/BSA index (p = 0.012), and sheath outer diameter (OD)/RD index (p = 0.024). CONCLUSION: In this prospective, randomized trial, the addition of a direct nitric oxide donor to nitroglycerin in an antispastic cocktail did not reduce the risk of spasm, and the use of nitroglycerin was found to be as effective as nitroprusside. Also, morphometric and mechanical factors play a significant role in predicting the occurrence of radial spasm. The sex of the patient, presence of diabetes, body surface area and smoking history appeared to play no role in predicting the occurrence of radial spasm.