Background Several studies, including three randomized controlled trials (RCTs), have shown that endovascular repair (EVAR) of abdominal aortic aneurysms (AAA) offered better early results than open ...surgical repair (OSR) but a similar medium-term to long-term mortality and a higher incidence of reinterventions. Thus, the role of EVAR, most notably in low-risk patients, remains debated. Methods The ACE (Anevrysme de l'aorte abdominale: Chirurgie versus Endoprothese) trial compared mortality and major adverse events after EVAR and OSR in patients with AAA anatomically suitable for EVAR and at low-risk or intermediate-risk for open surgery. A total of 316 patients with >5 cm aneurysms were randomized in institutions with proven expertise for both treatments: 299 patients were available for analysis, and 149 were assigned to OSR and 150 to EVAR. Patients were monitored for 5 years after treatment. Statistical analysis was by intention to treat. Results With a median follow-up of 3 years (range, 0-4.8 years), there was no difference in the cumulative survival free of death or major events rates between OSR and EVAR: 95.9% ± 1.6% vs 93.2% ± 2.1% at 1 year and 85.1% ± 4.5% vs 82.4% ± 3.7% at 3 years, respectively ( P = .09). In-hospital mortality (0.6% vs 1.3%; P = 1.0), survival, and the percentage of minor complications were not statistically different. In the EVAR group, however, the crude percentage of reintervention was higher (2.4% vs 16%, P < .0001), with a trend toward a higher aneurysm-related mortality (0.7% vs 4%; P = .12). Conclusions In patients with low to intermediate risk factors, open repair of AAA is as safe as EVAR and remains a more durable option.
Summary Background 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. Methods 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. Findings 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. Interpretation 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. Funding French Ministry of Health.
The main objectives of this expert consensus are to raise awareness about fibromuscular dysplasia, which is more frequent and more often systemic than previously thought and can sometimes have ...devastating consequences; to provide up-to-date recommendations for the diagnosis, evaluation, and management of the disease; and to identify research priorities. The emphasis has been put on recommendations for daily practice. The main topics covered include definition, classification, diagnosis, and management of fibromuscular dysplasia in adult patients with symptomatic involvement of the renal arteries, supra-aortic trunks, and digestive and peripheral arteries.
Dedicated catheters for hepatic arterial infusion chemotherapy were removed from the market. The purpose of this study was to assess the results of a novel approach to overcome the shortage of ...dedicated catheters for hepatic arterial infusion chemotherapy in the treatment of colorectal cancer liver metastases. We retrospectively included patients who underwent a percutaneous placement of a hepatic intra-arterial port catheter in a single tertiary center from February 2021 to June 2022. We examined the patient baseline characteristics, technical features of the modified procedures, technical success rates, complications and oncological outcomes. Fourteen patients (median age: 60 years; q1 = 54; q3 = 70; range: 53–81 years) underwent 15 modified procedures. The main modification of our placement technique consisted of the use of an indwelling 5-Fr Vertebral catheter, on the tip of which we created a two-sided additional lateral hole. The catheter was connected to a pediatric port. The primary success rate was 100%, and the secondary success rate was 93.3%. There were two late major complications, graded IIIa according to the Clavien–Dindo classification. The median liver progression free survival was 6.1 months (q1 = 2.5; q3 = 7.2; range: 1.3–11.6). Our experience suggests that the derived utilization of the devices used routinely in interventional radiology provides an effective solution that can compensate for the shortage of dedicated devices.
This study reports the 12-month results of the RADIANCE-HTN (A Study of the ReCor Medical Paradise System in Clinical Hypertension) SOLO trial following unblinding of patients at 6 months.
The blood ...pressure (BP)–lowering efficacy and safety of endovascular ultrasound renal denervation (RDN) in the absence (2 months) and presence (6 months) of antihypertensive medications were previously reported.
Patients with daytime ambulatory BP ≥135/85 mm Hg after 4 weeks off medication were randomized to RDN (n = 74) or sham (n = 72) and maintained off medication for 2 months. A standardized medication escalation protocol was instituted between 2 and 5 months (blinded phase). Between 6 and 12 months (unblinded phase), patients received antihypertensive medications at physicians’ discretion. Outcomes at 12 months included medication burden, change in daytime ambulatory systolic BP (dASBP) and office or home systolic BP (SBP), visit-to-visit variability in SBP, and safety.
Sixty-five of 74 RDN patients and 67 of 72 sham patients had 12-month dASBP measurements. The proportion of patients on ≥2 medications (27.7% vs. 44.8%; p = 0.041), the number of medications (1.0 vs. 1.4; p = 0.015), and defined daily dose (1.4 vs. 2.2; p = 0.007) were less with RDN versus sham. The decrease in dASBP from baseline in the RDN group (−16.5 ± 12.9 mm Hg) remained stable at 12 months. The RDN versus sham adjusted difference at 12 months was −2.3 mm Hg (95% confidence interval CI: −5.9 to 1.3 mm Hg; p = 0.201) for dASBP, −6.3 mm Hg (95% CI: −11.1 to −1.5 mm Hg; p = 0.010) for office SBP, and −3.4 mm Hg (95% CI: −6.9 to 0.1 mm Hg; p = 0.062) for home SBP. Visit-to-visit variability in SBP was smaller in the RDN group. No renal artery injury was detected on computed tomographic or magnetic resonance angiography.
Despite unblinding, the BP-lowering effect of RDN was maintained at 12 months with fewer prescribed medications compared with sham.
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The purpose of this study was to report the effectiveness and safety of selective arterial embolization for the management of anticoagulation-related soft-tissue bleeding.
All consecutive patients ...from June 1, 2003, to June 1, 2010, with intractable anticoagulation-related soft-tissue bleeding treated by embolization were included. The clinical files, MDCT angiographic examinations, and procedure details were reviewed. The primary goal of this study was to report the safety and efficacy of embolization for the management of anticoagulation-related soft-tissue bleeding. The secondary goal was to evaluate the correlation between the MDCT angiography (MDCTA) findings and conventional catheter angiography.
Thirty-six consecutive patients were included. All patients were under anticoagulant therapy. Overdosage of the anticoagulant was found in 12 (33%) patients. MDCT was performed with multiphasic contrast media injection in 30 patients (83%) and showed extravasation in 22 (73.3%) of those 30 patients. Catheter angiography revealed extravasation in 27 of 36 (75%) patients, and no active bleeding was observed in nine patients who were empirically embolized. The sensitivity of MDCTA for depicting ongoing active bleeding was 87%. The transfusion requirement for RBC units decreased from 4.0 (range, 0-12.0) before to 0 (range, 0-4.0) after embolization. Nine patients underwent a second embolization but only one in the same vascular territory. Eleven patients died within 30 days despite the embolization. No complications related to embolization were reported.
Anticoagulation-related soft-tissue bleeding can be efficiently and safely treated by selective arterial embolization. However, this serious pathologic condition may be fatal in many cases, and rebleeding is not rare. MDCTA could help to guide treatment.
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.
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