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74
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"Marc Sapoval"
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Optimum and stepped care standardised antihypertensive treatment with or without renal denervation for resistant hypertension (DENERHTN): a multicentre, open-label, randomised controlled trial
2015
Conflicting blood pressure-lowering effects of catheter-based renal artery denervation have been reported in patients with resistant hypertension. We compared the ambulatory blood pressure-lowering efficacy and safety of radiofrequency-based renal denervation added to a standardised stepped-care antihypertensive treatment (SSAHT) with the same SSAHT alone in patients with resistant hypertension.
The Renal Denervation for Hypertension (DENERHTN) trial was a prospective, open-label randomised controlled trial with blinded endpoint evaluation in patients with resistant hypertension, done in 15 French tertiary care centres specialised in hypertension management. Eligible patients aged 18–75 years received indapamide 1·5 mg, ramipril 10 mg (or irbesartan 300 mg), and amlodipine 10 mg daily for 4 weeks to confirm treatment resistance by ambulatory blood pressure monitoring before randomisation. Patients were then randomly assigned (1:1) to receive either renal denervation plus an SSAHT regimen (renal denervation group) or the same SSAHT alone (control group). The randomisation sequence was generated by computer, and stratified by centres. For SSAHT, after randomisation, spironolactone 25 mg per day, bisoprolol 10 mg per day, prazosin 5 mg per day, and rilmenidine 1 mg per day were sequentially added from months two to five in both groups if home blood pressure was more than or equal to 135/85 mm Hg. The primary endpoint was the mean change in daytime systolic blood pressure from baseline to 6 months as assessed by ambulatory blood pressure monitoring. The primary endpoint was analysed blindly. The safety outcomes were the incidence of acute adverse events of the renal denervation procedure and the change in estimated glomerular filtration rate from baseline to 6 months. This trial is registered with ClinicalTrials.gov, number NCT01570777.
Between May 22, 2012, and Oct 14, 2013, 1416 patients were screened for eligibility, 106 of those were randomly assigned to treatment (53 patients in each group, intention-to-treat population) and 101 analysed because of patients with missing endpoints (48 in the renal denervation group, 53 in the control group, modified intention-to-treat population). The mean change in daytime ambulatory systolic blood pressure at 6 months was −15·8 mm Hg (95% CI −19·7 to −11·9) in the renal denervation group and −9·9 mm Hg (−13·6 to −6·2) in the group receiving SSAHT alone, a baseline-adjusted difference of −5·9 mm Hg (−11·3 to −0·5; p=0·0329). The number of antihypertensive drugs and drug-adherence at 6 months were similar between the two groups. Three minor renal denervation-related adverse events were noted (lumbar pain in two patients and mild groin haematoma in one patient). A mild and similar decrease in estimated glomerular filtration rate from baseline to 6 months was observed in both groups.
In patients with well defined resistant hypertension, renal denervation plus an SSAHT decreases ambulatory blood pressure more than the same SSAHT alone at 6 months. This additional blood pressure lowering effect may contribute to a reduction in cardiovascular morbidity if maintained in the long term after renal denervation.
French Ministry of Health.
Journal Article
Prime Time for Artificial Intelligence in Interventional Radiology
by
Boeken, Tom
,
Sapoval, Marc
,
Goh, Gerard S
in
Artificial intelligence
,
Deep learning
,
Learning algorithms
2022
Machine learning techniques, also known as artificial intelligence (AI), is about to dramatically change workflow and diagnostic capabilities in diagnostic radiology. The interest in AI in Interventional Radiology is rapidly gathering pace. With this early interest in AI in procedural medicine, IR could lead the way to AI research and clinical applications for all interventional medical fields. This review will address an overview of machine learning, radiomics and AI in the field of interventional radiology, enumerating the possible applications of such techniques, while also describing techniques to overcome the challenge of limited data when applying these techniques in interventional radiology. Lastly, this review will address common errors in research in this field and suggest pathways for those interested in learning and becoming involved about AI.
Journal Article
Two-Year Outcomes of Prostatic Artery Embolization for Symptomatic Benign Prostatic Hyperplasia: An International, Multicenter, Prospective Study
2024
Purpose
To describe clinical outcomes among patients with benign prostatic hyperplasia (BPH) 24 months following prostatic artery embolization (PAE).
Materials and Methods
This was an international, multicenter, prospective trial of males with BPH with lower urinary tract symptoms (LUTS) or acute urinary retention (AUR) treated with PAE. The primary outcome was the 12 month change in the International Prostate Symptom Score (IPSS) for patients referred for bothersome LUTS, or urinary catheter independence for patients treated for AUR. Secondary outcome measures included changes in IPSS at 3 and 24 months, changes in quality of life (QoL), changes in the Sexual Health Inventory for Men (SHIM) questionnaire, technical success rate, and adverse events (AEs). Data were summarized using descriptive statistics.
Results
Four hundred seventy-eight consecutive patients underwent PAE (bothersome LUTS: N = 405; AUR: N = 73), mean age was 70 years. For patients treated for bothersome LUTS, mean total IPSS at baseline was 21.8 and decreased to 9.3, 10.6, and 11.2 at 3, 12, and 24 months following PAE, respectively (all
p
< 0.001); QoL at baseline was 4.7 and decreased to 2.0, 2.1, and 2.3 at 3, 12, and 24 months, respectively (all
p
< 0.001). The mean SHIM score at baseline and 12 months following PAE was 13.8 and 13.9, respectively. Of the 73 patients treated for AUR, 48 (65.8%) had their indwelling catheter removed within 3 months of PAE and remained catheter free at 24 months. Fifty-five patients (11.5%) experienced ≥ 1 AE and 10 (2.1%) experienced a serious AE.
Conclusion
PAE is a safe and effective treatment for symptomatic BPH and LUTS.
Level of Evidence
Level 3
Trial registration
ClinicalTrials.gov NCT03527589.
Graphical Abstract
Journal Article
Ruptured pulmonary artery pseudoaneurysm treated with stent graft: case report and literature review
2022
Background
Hemoptysis is a severe condition, associated with a high mortality rate from asphyxiation. Less than 5% of cases come from the pulmonary arterial circulation and large pseudoaneurysm are rarely treatable by stent graft.
Case presentation
We present the case of a 74-year-old man who suffered from a new onset of hemoptysis despite a prior bronchial artery embolization. He underwent a rescue endovascular stent graft placement for a massive hemoptysis caused by a ruptured proximal pulmonary artery pseudoaneurysm. A short review of similar situations is provided.
Conclusion
Salvage endovascular stent graft placement for a massive hemoptysis caused by a ruptured proximal pulmonary artery pseudoaneurysm is a viable salvage technique for life-threatening hemoptysis.
Journal Article
Fertility outcomes after uterine artery embolization for symptomatic leiomyomas
2025
Background
Uterine artery embolization (UAE) is a recognized treatment for symptomatic fibroids, but its impact on fertility remains controversial. This study aimed to assess live birth rates, pregnancy outcomes, and obstetric complications in patients attempting pregnancy after UAE.
Materials and methods
We conducted a retrospective monocentric study including women aged 18–45 years treated by UAE for symptomatic fibroids between June 2007 and March 2021. Patients who attempted pregnancy post-procedure were identified and analyzed. The primary outcome was the live birth rate; secondary outcomes included pregnancy rate and obstetric complications. Statistical analyses were performed according to the STROBE guidelines.
Results
Among 210 included patients, 46 attempted pregnancy (22%). The mean age of this fertility population was 40 years. Thirteen women (28%) began at least one pregnancy after UAE, resulting in 12 births overall in 9 mothers. All live births were delivered via cesarean section, and no fatal obstetric complications occurred in this cohort. The miscarriage rate (23%) and other obstetric outcomes were consistent with general population trends for similar age groups. UAE demonstrated high symptom resolution, with 70% of patients requiring no further interventions for fibroids.
Conclusion
Fertility may be preserved in a subset of women with complex surgical histories or high-risk surgical profiles undergoing UAE for symptomatic fibroids.
Trial registration
NCT05271981
Journal Article
Endovascular treatment of a subclavian artery pseudoaneurysm in a patient with a pancoast tumor
2025
Background
The authors report herein a rare case of an endovascular management of a giant subclavian artery pseudoaneurysm, revealed by a massive hemoptysis in a patient suffering from a Pancoast tumor.
Case presentation
The endovascular procedure consisted of covering the subclavian artery rupture site with a stent graft after occluding the proximal segments of the ipsilateral internal thoracic and vertebral arteries.
Conclusion
Subclavian artery rupture was effectively managed using endovascular techniques via radial access.
Journal Article
Safety and efficacy of the VenaTech™ Retrievable inferior vena cava filter: a first-in-man single-center prospective study
by
Pellerin, Oliver
,
Kim, Young Il
,
Martelli, Nicolas
in
Anticoagulants
,
Blood clots
,
Contraindications
2022
Background
Venous thromboembolism (VTE) is a frequent condition worldwide, associated with significant morbidity and mortality. Though its primary treatment is anticoagulation, the placement of an inferior vena cava (IVC) filter is recommended in patients with some comorbidities. The objectives of this study were to evaluate the clinical safety and efficacy of the Venatech® retrievable IVC filter. This open-label prospective single-center study was conducted on 40 consecutive patients requiring temporary or permanent IVC filtration. Patient characteristics, technical success rates of filter placement and removal, and the occurrence of complications were assessed. Follow-up imaging was performed using CT-scan before retrieval or at 6 months in the permanent indication population.
Results
The filter was successfully implanted at the intended location in all the patients. Retrieval was attempted in 21 (52.5%) patients after a mean period of 50 days (range: 6–94 days), and the filter was successfully removed in 18 patients (85.7%). Reason for retrieval failure was filter with trapped thrombus (
n
= 2) and a > 15° tilt (
n
= 1). No complication was observed during the filter placement and retrieval. Follow-up imaging available in 30 patients (75%) demonstrated deep filter penetration (> 3 mm) in four patients (13.3%), severe filter tilt (> 15
o
) in five patients (16.7%), filter with trapped thrombus in three patients (10%), but no fracture or IVC thrombosis.
Conclusion
This prospective study showed encouraging preliminary results of the safety and efficacy of the Venatech® retrievable IVC filter. The filter was easily delivered in the intended position and successfully removed in a high percentage of patients.
Trial registration
ClinicalTrials.gov
Identifier: NCT02674672
Journal Article
Women Specific Characteristics and 1-Year Outcome Among Patients Hospitalized for Peripheral Artery Disease: A Monocentric Cohort Analysis in a Tertiary Center
by
Mohamedi, Nassim
,
Khider, Lina
,
Messas, Emmanuel
in
Amputation
,
Cardiovascular disease
,
Chronic obstructive pulmonary disease
2022
Although women have lower age-standardized cardiovascular disease incidence, prevalence, and death-related rates than men, there are also reports indicating that women with cardiovascular disease receive less care, fewer investigations, and have poorer outcomes after a coronary event. The aims of this study were to compare the characteristics of men and women hospitalized for peripheral artery disease (PAD), their cardiovascular and limb outcomes, and their 1-year mortality. The study is a prospective registry collecting data about all consecutive patients hospitalized for PAD within the vascular department of the tertiary center Georges-Pompidou European Hospital (Paris, France). Patients were required to have one of three inclusion criteria: previous revascularization of the lower limb or any lower limb artery occlusion due to an atherosclerotic vascular disease or hemodynamic evidence of PAD. Exclusion criteria were patients with lower extremity arterial occlusion due to another cause. All patients were followed-up for at least 12 months after the initial hospitalization. Among the 235 patients included, there were 61 women (26%), older than men with a median age of 75.6 and 68.3 years, respectively. Main cardiovascular risk factors and comorbidities were similar for men and women except more former or current smokers [145 (83.4%) vs. 33 (54.1%)] and more history of coronary heart disease [42 (24.1%) vs. 7 (11.5%)] in men. Most patients [138 (58.8%)] had critical limb ischemia and 97 (41.3%) had claudication, with no difference for sex. After discharge, 218 patients received an antithrombotic therapy (93.2%), 195 a lipid-lowering drug (83.3%), 185 an angiotensin converting enzyme inhibitor or angiotensin-receptor blocker (78.9%), similarly between sex. At 1-year, overall mortality, major adverse cardiovascular events, major adverse limb events did not differ with 23 (13.2%), 11 (6.3%) and 32 (18.4%) in men, and 8 (13.1%), 3 (4.9%), 15 (24.6%) in women, respectively, despite the difference in age. Overall mortality, cardiovascular outcomes, limb revascularization or amputation did not differ between men and women, 1-year after hospitalization for PAD although the latter were older, less smoker and had less coronary artery disease. Due to the small size of this cohort, larger studies and future research are needed to better understand sex-specific mechanisms in the pathophysiology and natural history of PAD.
Journal Article