Standardized Data Elements for Patients With Acute Pulmonary Embolism: A Consensus Report From the Pulmonary Embolism Research Collaborative.

Recent advances in therapy and the promulgation of multidisciplinary pulmonary embolism teams show great promise to improve management and outcomes of acute pulmonary embolism (PE). However, the absence of randomized evidence and lack of consensus leads to tremendous variations in treatment and compromises the wide implementation of new innovations. Moreover, the changing landscape of health care, where quality, cost, and accountability are increasingly relevant, dictates that a broad spectrum of outcomes of care must be routinely monitored to fully capture the impact of modern PE treatment. We set out to standardize data collection in patients with PE undergoing evaluation and treatment, and thus establish the foundation for an expanding evidence base that will address gaps in evidence and inform future care for acute PE. To do so, >100 international PE thought leaders convened in Washington, DC, in April 2022 to form the Pulmonary Embolism Research Collaborative. Participants included physician experts, key members of the US Food and Drug Administration, patient representatives, and industry leaders. Recognizing the multidisciplinary nature of PE care, the Pulmonary Embolism Research Collaborative was created with representative experts from stakeholder medical subspecialties, including cardiology, pulmonology, vascular medicine, critical care, hematology, cardiac surgery, emergency medicine, hospital medicine, and pharmacology. A list of critical evidence gaps was composed with a matching comprehensive set of standardized data elements; these data points will provide a foundation for productive research, knowledge enhancement, and advancement of clinical care within the field of acute PE, and contribute to answering urgent unmet needs in PE management. Evidence produced through the Pulmonary Embolism Research Collaborative, as it is applied to data collection, promises to provide crucial knowledge that will ultimately produce a robust evidence base that will lead to standardization and harmonization of PE management and improved outcomes.

Antithrombotic Therapy in Patients Undergoing Peripheral Artery Interventions.

Patients with peripheral artery disease (PAD) who undergo lower extremity revascularization (LER) are at high risk for cardiovascular and limb-related ischemic events. The role of antithrombotic therapy is to prevent thrombotic complications, but this requires balancing increased risk of bleeding events. The dual pathway inhibition (DPI) strategy including aspirin and low-dose rivaroxaban after LER has been shown to reduce major adverse cardiovascular and limb-related events without significant differences in major bleeding. There is now a need to implement the broad adoption of DPI therapy in PAD patients who have undergone LER in routine practice.

The influence of patient sex on pulmonary embolism evaluation, treatment modality, and outcomes.

BACKGROUND: Pulmonary embolism (PE) is the third-leading cause of cardiovascular mortality, accounting for 100,000 deaths per year in the United States. Although sex-based disparities have previously been described in this population, it is unclear if these differences have persisted with the expansion of PE evaluation and treatment approaches. The purpose of this study is to investigate sex-based differences in the evaluation, management, and outcomes of patients with acute PE. METHODS: We performed a retrospective analysis of patients enrolled in the national Pulmonary Embolism Response Team (PERT) Consortium database between October 2015 and October 2022. We evaluated patient demographics, clinical characteristics, diagnostic imaging performed, treatment at several phases of care (pre-PERT, PERT recommendations, and post-PERT), and clinical outcomes. RESULTS: A total of 5722 patients with acute PE (2838 [49.6%] women) from 35 centers were included. There were no differences in PE risk category between male and female patients. Women were less likely to undergo echocardiography (76.9% vs 73.8%) and more likely to receive no anticoagulation prior to PERT evaluation (35.5% vs 32.9%). PERT teams were more likely to recommend catheter-based interventions for men (26.6% vs 23.1%), and men were more likely to undergo these procedures (21.9% vs 19.3%). In a multivariable analysis, female sex was a predictor of in-hospital mortality (OR 1.53, 95% CI 1.06 to 2.21). CONCLUSIONS: In this analysis, we identified sex-based differences in the evaluation and management of patients presenting with acute PE. Subsequently, women presenting with acute PE were at higher risk of in-hospital mortality.

Intravascular Ultrasound Use in Peripheral Arterial and Deep Venous Interventions: Multidisciplinary Expert Opinion From SCAI/AVF/AVLS/SIR/SVM/SVS.

Percutaneous revascularization is the primary strategy for treating lower extremity venous and arterial disease. Angiography is limited by its ability to accurately size vessels, precisely determine the degree of stenosis and length of lesions, characterize lesion morphology, or correctly diagnose postintervention complications. These limitations are overcome with use of intravascular ultrasound (IVUS). IVUS has demonstrated the ability to improve outcomes following percutaneous coronary intervention, and there is increasing evidence to support its benefits in the setting of peripheral vascular intervention. At this stage in its evolution, there remains a need to standardize the use and approach to peripheral vascular IVUS imaging. This manuscript represents considerations and consensus perspectives that emerged from a roundtable discussion including 15 physicians with expertise in interventional cardiology, interventional radiology, and vascular surgery, representing 6 cardiovascular specialty societies, held on February 3, 2023. The roundtable's aims were to assess the current state of lower extremity revascularization, identify knowledge gaps and need for evidence, and determine how IVUS can improve care and outcomes for patients with peripheral arterial and deep venous pathology.

Short and Midterm Outcomes of Percutaneous Deep Venous Arterialisation for No Option Chronic Limb Threatening Ischaemia: A Systematic Review and Meta-Analysis.

OBJECTIVE: Percutaneous deep venous arterialisation (pDVA) is a state of the art technique for treating patients with chronic limb threatening ischaemia (CLTI) with no conventional option for revascularisation. There are limited large scale data examining the clinical effectiveness of pDVA for patients with end stage CLTI. DATA SOURCES: MEDLINE, Embase, Google Scholar, and Cochrane databases. REVIEW METHODS: Four databases were searched from January 2018 to June 2024 to identify studies investigating the feasibility and clinical outcomes of pDVA for patients with CLTI with no conventional revascularisation options. Meta-analysis of time to event outcomes (mean ± standard deviation) was performed for amputation free survival as the primary outcome, and freedom from amputation and overall survival as secondary outcomes. Other secondary outcomes (mean and 95% confidence interval [CI]) were procedural success rate, patency, re-intervention, and complete wound healing. RESULTS: Ten non-randomised studies were included with 351 patients. The mean patient age was 70.3 years, and 67.6% were male. Most procedures used the posterior tibial artery. The aggregated rate of amputation free survival at six and twelve months (five studies, 260 patients) was 72.6 ± 2.8% and 66.0 ± 3.1%, respectively, while the overall survival at six and twelve months (five studies, 260 patients) was 85.0 ± 2.3% and 77.7 ± 2.9%, respectively. The procedural success rate (nine studies, 330 patients) was 95.5% (95% CI 92.4 - 98.7%). Primary and secondary patency at six months (four studies, 241 patients) was 23.4% (95% CI 13.6 - 33.2%) and 54.9% (95% CI 34.3 - 75.5%), respectively. The rates of re-intervention (four studies, 190 patients) and complete wound healing (five studies, 190 patients) at twelve months were 41.7% (95% CI 25.7 - 57.7%) and 46.0% (95% CI 31.7 - 60.3%), respectively. CONCLUSION: This meta-analysis demonstrated acceptable feasibility for no option CLTI at highly specialised institutions for patients undergoing pDVA. Meta-analysis of time to event outcomes revealed that pDVA provides reasonable amputation free survival for up to twelve months, albeit with a overall low certainty of evidence. Wider adoption of pDVA may be considered in selected patients with CLTI, although its clinical impact and cost effectiveness require further evaluation.

Use of Calcium Modification During Percutaneous Coronary Intervention After Introduction of Coronary Intravascular Lithotripsy.

Background: Calcified coronary lesions are a challenge for percutaneous coronary interventions (PCIs). Coronary intravascular lithotripsy (IVL) is a novel calcium modification technology approved for commercial use in February 2021, but little is known about its uptake in US clinical practice. Methods: We described trends in use of calcium modification strategies, variation in use across hospitals, and predictors of calcium modification and IVL use in PCI. We included National Cardiovascular Data Registry CathPCI Registry patients who underwent PCI between April 1, 2018, and December 31, 2022. We examined trends and hospital variation in calcium modification and IVL use. We used multivariate hierarchical logistic regression to identify predictors of calcium modification and IVL use at hospitals in 2022. Results: Of 2,733,494 PCIs across 1676 hospitals over 4.75 years, 11.4% were performed with calcium modification. Coronary IVL use increased rapidly from 0% of PCIs in Q4 2020 to 7.8% of PCIs in Q4 2022, which was accompanied by an overall increase in use of all calcium modification strategies (11.1%-16.0%) during this period with a slight corresponding decrease in coronary atherectomy use (5.4%-4.4%). In 2022, there was wide variation in IVL use across hospitals (median, 3.86%; IQR, 0%-8.19%), with IVL being the most common calcium modification strategy in 48% of hospitals. The treating hospital was the strongest predictor of calcium modification (median odds ratio [OR], 2.49; 95% CI, 2.40-2.57) and IVL use (median OR, 2.89; 95% CI, 2.74-3.04). Conclusions: IVL has rapidly changed the landscape of calcium modification use for PCI, although there remains wide variation across hospitals.

A Safety and Feasibility Single-Arm Study of a Novel Catheter Thrombectomy Device for the Treatment of Pulmonary Embolism (ENGULF).

Background: Despite advances in therapy options, pulmonary embolism (PE) continues to carry a high risk of mortality and morbidity. Currently, therapeutic options are limited with only 2 US Food and Drug Administration-cleared catheter-based embolectomy devices approved for the treatment of intermediate-risk PE. The novel Helo PE thrombectomy catheter (Endovascular Engineering, Inc) has a flexible and collapsible funnel with an internal agitator for a dual mechanism of treatment for acute PE. We sought to investigate the safety and feasibility of the novel Helo PE thrombectomy catheter in intermediate-risk PE. Methods: A prospective, single-arm feasibility study evaluating the Helo PE catheter was performed in patients presenting with intermediate-risk PE. Patients underwent preprocedural and postprocedural computed tomography angiography. Primary efficacy was the difference in preprocedural to postprocedural right ventricle/left ventricle (RV/LV) ratio. Primary and secondary safety outcomes were all-cause mortality, major life-threatening bleeding, device-related serious adverse events, pulmonary or cardiac injury, and clinical decompensation at 48 hours postprocedure and at 30 days. Results: A total of 25 patients from 8 centers were consented and included in the analysis. Preprocedural computed tomography angiography revealed an RV/LV ratio of 1.53 ± 0.27. All patients underwent a successful thrombectomy procedure. Postprocedure, the RV/LV ratio was reduced to 1.15 ± 0.18, translating into a 23.2 ± 12.81% decrease from baseline. No patients underwent adjunctive thrombolysis. Two patients had adjunctive catheter-directed embolectomy with an alternative device. Two patients had postprocedural anemia requiring transfusion but did not meet criteria for major life-threatening bleeding by VARC-2 criteria. There were no major adverse events including no deaths, major bleeding, pulmonary injury, or vascular complications at 48 hours or 30 days post procedure. Conclusions: In this multicenter first-in-human study, use of the Helo PE thrombectomy catheter was feasible and safe for the treatment of acute PE.

Procedural Feasibility and Peri-procedural Outcomes of Peripheral Endovascular Therapy via Transradial versus Transfemoral Access: A Systematic Review and Meta-Analysis.

OBJECTIVE: This systematic review and meta-analysis aimed to evaluate the safety and feasibility of transradial access for peripheral vascular interventions. DATA SOURCES: MEDLINE and Embase. REVIEW METHODS: MEDLINE and Embase databases were searched to June 2023 to identify studies investigating the outcomes of lower extremity, carotid, and visceral artery vascular interventions via transradial vs. transfemoral access. The primary outcome was procedural failure rate. Secondary outcomes were total access site complications, minor and major bleeding, stroke, access vessel occlusion, procedure time, fluoroscopy time, and contrast volume. RESULTS: Eight randomised controlled trials and 29 observational studies yielded a total of 70 882 patients treated via transradial (n = 2 616) vs. transfemoral access (n = 68 338). The overall failure rate was 2.3 ± 0.7%, and the transradial approach was associated with a statistically significantly higher procedural failure rate than the transfemoral approach (3.9 ± 0.7% vs. 1.0 ± 0.3%; odds ratio [OR] 3.07, 95% confidence interval [CI] 1.84 - 5.12; I2 = 32%; p < .001). Subgroup analysis showed the highest failure rate in lower extremity interventions with 12.4 ± 4.9% for transradial vs. 4.0 ± 1.2% for transfemoral access. Conversely, procedural complications were statistically significantly fewer with transradial access for total access site complications (OR 0.64, 95% CI 0.45 - 0.91; I2 = 36%; p = .010). Minor bleeding was statistically significantly less with the transradial approach (OR 0.52, 95% CI 0.31 - 0.86; I2 = 30%; p = .010), whereas major bleeding and stroke rates were similar. Transradial access had more access vessel occlusion than transfemoral access (1.9% ± 0.5% vs. < 0.1% ± 0.0%; p = .004), although most remained asymptomatic. Procedure time, fluoroscopy time, and contrast volume were all comparable. GRADE certainty was low to moderate in most outcomes. CONCLUSION: The transradial approach was associated with a higher procedural failure rate. Total access site complications and minor bleeding were lower with the transradial approach, albeit with more frequent access vessel occlusion. Transradial access may be a feasible and safe approach; however, appropriate patient selection is imperative.

Consensus Statement on the Management of Nonthrombotic Iliac Vein Lesions From the VIVA Foundation, the American Venous Forum, and the American Vein and Lymphatic Society.

A nonthrombotic iliac vein lesion is defined as the extrinsic compression of the iliac vein. Symptoms of lower extremity chronic venous insufficiency or pelvic venous disease can develop secondary to nonthrombotic iliac vein lesion. Anatomic compression has been observed in both symptomatic and asymptomatic patients. Causative factors that lead to symptomatic manifestations remain unclear. To provide guidance for providers treating patients with nonthrombotic iliac vein lesion, the VIVA Foundation convened a multidisciplinary group of leaders in venous disease management with representatives from the American Venous Forum and the American Vein and Lymphatic Society. Consensus statements regarding nonthrombotic iliac vein lesions were drafted by the participants to address patient selection, imaging for diagnosis, technical considerations for stent placement, postprocedure management, and future research/educational needs.

Impact of Cerebral Embolic Protection Devices on Disabling Stroke After TAVR: Updated Results From the STS/ACC TVT Registry.

BACKGROUND: Cerebral embolic protection devices (EPDs) were developed to mitigate the risk of stroke during transcatheter aortic valve replacement (TAVR), but their benefit remains unproven. In the PROTECTED-TAVR trial (Stroke Protection With Sentinel During Transcatheter), EPD use did not reduce periprocedural stroke (primary study outcome) but led to a 62% reduction in the secondary end point of disabling stroke. Given these results, the impact of EPDs during TAVR remains unclear. METHODS: We used STS/ACC TVT registry data to examine the association between EPD use and a proxy for disabling stroke among transfemoral TAVR patients between January 2018 and June 2023. The primary outcome was in-hospital disabling stroke-defined as stroke associated with either in-hospital death or discharge to a nonhome location. We evaluated the association between EPD use and disabling stroke using instrumental variable analysis with a site-level preference for EPD use as the instrument-a quasi-experimental approach that can support causal inference. In addition, we performed a propensity score-based comparison using overlap weighting as a secondary analysis. RESULTS: The study population consisted of 414 649 patients of whom 53 389 (12.9%) received an EPD. The unadjusted rate of in-hospital disabling stroke was 0.7% among the EPD group and 0.9% in the no-EPD group. EPD use was associated with a reduction in disabling stroke in both instrumental variable analysis (relative risk, 0.87 [95% CI, 0.73-1.00]) and propensity-weighted analysis (odds ratio, 0.79 [95% CI, 0.70-0.90]) but was not associated with a reduction in nondisabling stroke. In subgroup analyses, the benefit of EPD was greater among those with versus without prior stroke (Pinteraction<0.05 for both instrumental variable and propensity-weighted analyses). CONCLUSIONS: In the largest study to date, among patients undergoing TAVR, EPD use was associated with a small, borderline significant reduction in stroke associated with death or discharge to a nonhome location (a proxy for disabling stroke) that is likely to be causal in nature. Taken together with previous mechanistic and clinical studies, these findings provide credible evidence that EPDs benefit patients undergoing TAVR.

Using Separate Single-Outcome Risk Presentations Instead of Integrated Multioutcome Formats Improves Comprehension in Discrete Choice Experiments.

INTRODUCTION: Despite decades of research on risk-communication approaches, questions remain about the optimal methods for conveying risks for different outcomes across multiple time points, which can be necessary in applications such as discrete choice experiments (DCEs). We sought to compare the effects of 3 design factors: 1) separated versus integrated presentations of the risks for different outcomes, 2) use or omission of icon arrays, and 3) vertical versus horizontal orientation of the time dimension. METHODS: We conducted a randomized study among a demographically diverse sample of 2,242 US adults recruited from an online panel (mean age 59.8 y, s = 10.4 y; 21.9% African American) that compared risk-communication approaches that varied in the 3 factors noted above. The primary outcome was the number of correct responses to 12 multiple-choice questions asking survey respondents to identify specific numbers, contrast options to recognize dominance (larger v. smaller risks), and compute differences. We used linear regression to test the effects of the 3 design factors, controlling for health literacy, graph literacy, and numeracy. We also measured choice consistency in a subsequent DCE choice module. RESULTS: Mean comprehension varied significantly across versions (P < 0.001), with higher comprehension in the 3 versions that provided separated risk information for each risk. In the multivariable regression, separated risk presentation was associated with 0.58 more correct responses (P < 0.001; 95% confidence interval: 0.39, 0.77) compared with integrated risk information. Neither providing icon arrays nor using vertical versus horizontal time formats affected comprehension rates, although participant understanding did correlate with DCE choice consistency. CONCLUSIONS: In presentations of multiple risks over multiple time points, presenting risk information separately for each health outcome appears to increase understanding. HIGHLIGHTS: When conveying information about risks of different outcomes at multiple time points, separate presentations of single-outcome risks resulted in higher comprehension than presentations that combined risk information for different outcomes.We also observed benefits of presenting single-outcome risks separately among respondents with lower numeracy and graph literacy.Study participants who scored higher on risk understanding were more internally consistent in their responses to a discrete choice experiment.

Evaluating the Effectiveness of Systemic Heparin During Arteriovenous Fistula Creation by Emulating a Target Trial.

Most of the 800,000 people living with end-stage kidney disease in the United States rely on a functioning vascular access to provide life-sustaining hemodialysis, yet one-third of arteriovenous fistulas experience early failures. Determining the safety and effectiveness of systemic heparin during fistula creation could improve the quality and quantity of life for these vulnerable patients. In this paper, a pragmatic randomized trial was emulated to assess the effect of systemic heparin administration (vs. none) during radiocephalic arteriovenous fistula creation on early bleeding and thrombosis using data from two international multicenter randomized trials performed between 2014 and 2019. Marginal risks were estimated using inverse probability weighted parametric survival analysis and confidence intervals were generated with bootstrapping. A total of 914 patients were enrolled and 61% received systemic heparin; median (IQR) age was 58 (49, 67) years and 45% were on hemodialysis at enrollment. No difference in the risk of bleeding events was observed, with a risk difference (95% CI) at 14 days of -0.1% (-1.6, 1.4). The risk of access thrombosis was lower in the heparin group, with a risk of 3.7% (2.6, 4.8) after heparin and 5.3% (3.4, 7.4) without heparin at 14 days (risk ratio 0.72, 95% CI 0.50, 0.98).

Comparative Effectiveness of Intravascular Ultrasound Versus Angiography in Abdominal and Thoracic Endovascular Aortic Repair: Systematic Review and Meta-Analysis.

The effectiveness of intravascular ultrasound (IVUS) with angiography compared with angiography guidance alone in treating aortic conditions, such as dissections, aneurysms, and blunt traumatic injuries, remains unclear. This systematic review and meta-analysis evaluates the current literature for IVUS use during thoracic endovascular aortic repair (TEVAR) and abdominal endovascular aortic repair (EVAR). A comprehensive search of MEDLINE, EMBASE, and Cochrane CENTRAL databases was conducted in March 2024 adhering to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Studies comparing outcomes of TEVAR/EVAR with and without IVUS were identified. The outcomes of interest included contrast volume, fluoroscopy and procedural time, perioperative endoleak, and reinterventions and all-cause mortality during follow-up. Data with 95% confidence intervals (CIs) were extracted. Pooled analysis was performed using a random-effect model. Subgroup analysis was performed stratified by the condition being treated. Risk of bias was assessed using the Newcastle-Ottawa Scale for observational studies. A total of 4,219 patients (n = 2,655 IVUS and n = 1,564 non-IVUS) from 9 observational studies were included. The IVUS group exhibited a reduction in contrast agent volume (weighted mean difference -34.65 mL, 95% CI -54.73 to -14.57) and fluoroscopy time (weighted mean difference -6.13 minutes, 95% CI -11.10 to -1.15), with no difference in procedural time. The perioperative type I and III endoleak occurrences were similar (risk ratio 2.36, 95% CI 0.55 to 10.11; risk ratio 0.72, 95% CI 0.09 to 5.77, respectively). Reintervention and mortality during follow-up were comparable (hazard ratio 0.80, 95% CI 0.33 to 1.97; hazard ratio 0.75, 95% CI 0.47 to 1.18, respectively). All the included studies had small risks of bias. In conclusion, this meta-analysis provides evidence that IVUS enables the safe deployment of TEVAR/EVAR with reduced contrast agent and radiation exposure.

2024 ACC/AHA/AACVPR/APMA/ABC/SCAI/SVM/SVN/SVS/SIR/VESS Guideline for the Management of Lower Extremity Peripheral Artery Disease: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines.

AIM: The "2024 ACC/AHA/AACVPR/APMA/ABC/SCAI/SVM/SVN/SVS/SIR/VESS Guideline for the Management of Lower Extremity Peripheral Artery Disease" provides recommendations to guide clinicians in the treatment of patients with lower extremity peripheral artery disease across its multiple clinical presentation subsets (ie, asymptomatic, chronic symptomatic, chronic limb-threatening ischemia, and acute limb ischemia). METHODS: A comprehensive literature search was conducted from October 2020 to June 2022, encompassing studies, reviews, and other evidence conducted on human subjects that was published in English from PubMed, EMBASE, the Cochrane Library, CINHL Complete, and other selected databases relevant to this guideline. Additional relevant studies, published through May 2023 during the peer review process, were also considered by the writing committee and added to the evidence tables where appropriate. STRUCTURE: Recommendations from the "2016 AHA/ACC Guideline on the Management of Patients With Lower Extremity Peripheral Artery Disease" have been updated with new evidence to guide clinicians. In addition, new recommendations addressing comprehensive care for patients with peripheral artery disease have been developed.

2024 ACC/AHA/AACVPR/APMA/ABC/SCAI/SVM/SVN/SVS/SIR/VESS Guideline for the Management of Lower Extremity Peripheral Artery Disease: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines.

AIM: The "2024 ACC/AHA/AACVPR/APMA/ABC/SCAI/SVM/SVN/SVS/SIR/VESS Guideline for the Management of Lower Extremity Peripheral Artery Disease" provides recommendations to guide clinicians in the treatment of patients with lower extremity peripheral artery disease across its multiple clinical presentation subsets (ie, asymptomatic, chronic symptomatic, chronic limb-threatening ischemia, and acute limb ischemia). METHODS: A comprehensive literature search was conducted from October 2020 to June 2022, encompassing studies, reviews, and other evidence conducted on human subjects that was published in English from PubMed, EMBASE, the Cochrane Library, CINHL Complete, and other selected databases relevant to this guideline. Additional relevant studies, published through May 2023 during the peer review process, were also considered by the writing committee and added to the evidence tables where appropriate. STRUCTURE: Recommendations from the "2016 AHA/ACC Guideline on the Management of Patients With Lower Extremity Peripheral Artery Disease" have been updated with new evidence to guide clinicians. In addition, new recommendations addressing comprehensive care for patients with peripheral artery disease have been developed.

Opportunities and Limitations of Renal Denervation: Where Do We Stand?

Hypertension is a primary contributor to cardiovascular disease, and the leading risk factor for loss of quality adjusted life years. Up to 50% of the cases of hypertension in the United States remain uncontrolled. Additionally, 8%-18% of the hypertensive population have resistant hypertension; uncontrolled pressure despite 3 different antihypertensive agents. Recently, catheter-based percutaneous renal denervation emerged as a method for ablating renal sympathetic nerves for difficult-to-control hypertension. Initial randomized (non-sham) trials and registry analyses showed impressive benefit, but the first sham-controlled randomized controlled trial using monopolar radiofrequency ablation showed limited benefit. With refinement of techniques to include multipolar radiofrequency, ultrasound denervation, and direct ethanol injection, randomized controlled trials demonstrated significant blood pressure improvement, leading to US Food and Drug Administration approval of radiofrequency- and ultrasound-based denervation technologies. In this review article, we summarize the major randomized sham-controlled trials and societal guidelines regarding the efficacy and safety of renal artery denervation for the treatment of uncontrolled hypertension.