190 research outputs found

    Uterine Artery Embolization as an Alternative to Hysterectomy, in Patients with Uterine Myomas

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    Uterine artery embolization (UAE) is a minimal invasive technique that uses transcutaneous common femoral artery approach to block uterine blood supply

    Starclose SE® hemostasis after 6F direct antegrade superficial femoral artery access distal to the femoral head for peripheral endovascular procedures in obese patients

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    PURPOSE:Direct superficial femoral artery (SFA) antegrade puncture is a valid alternative to common femoral artery (CFA) access for peripheral vascular interventions. Data investigating vascular closure device (VCD) hemostasis of distant SFA 6F access are limited. We aimed to investigate the safety and effectiveness of the Starclose SE® VCD for hemostasis, following direct 6F antegrade SFA access distal to the femoral head.METHODS:This prospective, single-center study included patients who were not suitable for CFA puncture and were scheduled to undergo peripheral endovascular interventions using direct antegrade SFA 6F access, at least 2 cm below the inferior edge of femoral head. Hemostasis was obtained with the Starclose SE® VCD (Abbott Laboratories). Primary endpoints were successful hemostasis rate and periprocedural (30-day) major complication rate. Secondary endpoint was the rate of minor complications. Clinical and Doppler ultrasound follow-up was performed at discharge and at one month.RESULTS:Between September 2014 and August 2015, a total of 30 patients (21 male; 70.0%) with a mean body mass index of 41.2 kg/m2 were enrolled. Mean age was 72±9 years (range, 67–88 years). Most patients suffered from critical limb ischemia (87.1%) and diabetes (61.3%). Calcifications were present in eight cases (26.6%). Reason for direct SFA puncture was obesity (100%). Successful hemostasis was achieved in 100% of the cases. No major complications were noted after one-month follow-up. Minor complications included two <5 cm hematomas (6.6%) not necessitating treatment.CONCLUSION:In this prospective study, Starclose SE® VCD was safe and effective for hemostasis of antegrade direct SFA puncture. Uncomplicated hemostasis was achieved even in cases of puncturing 2 to 7 cm below the inferior edge of the femoral head

    Platelet Responsiveness to Clopidogrel Treatment After Peripheral Endovascular Procedures The PRECLOP Study: Clinical Impact and Optimal Cutoff Value of On-Treatment High Platelet Reactivity

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    ObjectivesThis study aimed to assess the clinical implications and optimal cutoff value of high platelet reactivity (HPR) in patients receiving clopidogrel for peripheral endovascular procedures.BackgroundAs noted in coronary studies, HPR could be related to increased adverse events.MethodsThis prospective trial included patients receiving clopidogrel 75 mg daily, before and after infrainguinal angioplasty or stenting. Platelet inhibition was assessed with the VerifyNow P2Y12 point-of-care test. Primary endpoints were 1-year clinical events rate (composite endpoint of death, major stroke, major amputation, target vessel revascularization, and bypass) according to the P2Y12 reaction units (PRU)-based quartile distribution, the estimation of the optimal PRU cutoff value for predicting clinical outcome, and the identification of independent predictors influencing event-free survival.ResultsIn total, 100 consecutive patients were enrolled. The 1-year cumulative events rate was 4% in the first quartile, 12% in the second, 52% in the third, and 84% in the fourth. Pairwise comparisons demonstrated a significant difference in the composite endpoint between successive quartiles (all p &lt; 0.05 except for the first vs. second quartile). According to receiver-operating characteristic curve analysis, the optimal cutoff value for the composite endpoint was PRU ≥234 (area under the curve: 0.883; 95% confidence interval [CI]: 0.811 to 0.954; p &lt; 0.0001; sensitivity: 92.1%; specificity: 84.2%). Cox multivariate regression analysis identified HPR (PRU ≥234) as the only independent predictor of an increased number of adverse events (hazard ratio: 16.9; 95% CI: 5 to 55; p &lt; 0.0001).ConclusionsOn-treatment HPR is associated with markedly increased adverse clinical events in patients undergoing peripheral endovascular procedures. Point-of-care clopidogrel assessment might be useful in individualizing antiplatelet therapy to attain superior clinical results. (High On-Treatment Platelet Reactivity Following Peripheral Endovascular Procedures [PRECLOP]; NCT01744613

    Emerging Stent and Balloon Technologies in the Femoropopliteal Arteries

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    Endovascular procedures for the management of the superficial femoral (SFA) and popliteal artery disease are increasingly common. Over the past decade, several stent technologies have been established which may offer new options for improved clinical outcomes. This paper reviews the current evidence for SFA and popliteal artery angioplasty and stenting, with a focus on randomized trials and registries of nitinol self-expanding stents, drug-eluting stents, dug-coated balloons, and covered stent-grafts. We also highlight the limitations of the currently available data and the future routes in peripheral arterial disease (PAD) stent and balloon technology

    Risk of Major Amputation Following Application of Paclitaxel Coated Balloons in the Lower Limb Arteries : A Systematic Review and Meta-Analysis of Randomised Controlled Trials

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    Objective: There have been concerns about the long term safety of paclitaxel coated devices in the lower limbs. A formal systematic review and meta-analysis of randomised controlled trials (RCTs) was performed to examine the long term risk of major amputation using paclitaxel coated balloons in peripheral arterial disease (PAD). Method: This systematic review was registered with PROSPERO (ID 227761). A broad bibliographic search was performed for RCTs investigating paclitaxel coated balloons in the peripheral arteries (femoropopliteal and infrapopliteal) for treatment of intermittent claudication or critical limb ischaemia (CLI). The literature search was last updated on 20 February 2021 without any restrictions on publication language, date, or status. Major amputations were analysed with time to event methods employing one and two stage models. Sensitivity and subgroup analyses, combinatorial meta-analysis, and a multivariable dose response meta-analysis to examine presence of a biological gradient were also performed. Results: In all, 21 RCTs with 3 760 lower limbs were analysed (52% intermittent claudication and 48% CLI; median follow up two years). There were 87 major amputations of 2 216 limbs in the paclitaxel arms (4.0% crude risk) compared with 41 major amputations in 1 544 limbs in the control arms (2.7% crude risk). The risk of major amputation was significantly higher for paclitaxel coated balloons with a hazard ratio (HR) of 1.66 (95% CI 1.14 - 2.42; p = .008, one stage stratified Cox model). The prediction interval was 95% CI 1.10 - 2.46 (two stage model). The observed amputation risk was consistent for both femoropopliteal (p = .055) and infrapopliteal (p = .055) vessels. Number needed to harm was 35 for CLI. There was good evidence of a significant non-linear dose response relationship with accelerated risk per cumulative paclitaxel dose (chi square model p = .007). There was no evidence of publication bias (p = .80) and no significant statistical heterogeneity between studies (I-2 = 0%, p = .77). Results were stable across sensitivity analyses (different models and subgroups based on anatomy and clinical indication and excluding unpublished trials). There were no influential single trials. Level of certainty in evidence was downrated from high to moderate because of sparse events in some studies. Conclusion: There appears to be heightened risk of major amputation after use of paclitaxel coated balloons in the peripheral arteries. Further investigations are warranted urgently.Peer reviewe

    Transauricular embolization of the rabbit coronary artery for experimental myocardial infarction: comparison of a minimally invasive closed-chest model with open-chest surgery

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    <p>Abstract</p> <p>Introduction</p> <p>To date, most animal studies of myocardial ischemia have used open-chest models with direct surgical coronary artery ligation. We aimed to develop a novel, percutaneous, minimally-invasive, closed-chest model of experimental myocardial infarction (EMI) in the New Zealand White rabbit and compare it with the standard open-chest surgical model in order to minimize local and systemic side-effects of major surgery.</p> <p>Methods</p> <p>New Zealand White rabbits were handled in conformity with the "Guide for the Care and Use of Laboratory Animals" and underwent EMI under intravenous anesthesia. Group A underwent EMI with an open-chest method involving surgical tracheostomy, a mini median sternotomy incision and left anterior descending (LAD) coronary artery ligation with a plain suture, whereas Group B underwent EMI with a closed-chest method involving fluoroscopy-guided percutaneous transauricular intra-arterial access, superselective LAD catheterization and distal coronary embolization with a micro-coil. Electrocardiography (ECG), cardiac enzymes and transcatheter left ventricular end-diastolic pressure (LVEDP) measurements were recorded. Surviving animals were euthanized after 4 weeks and the hearts were harvested for Hematoxylin-eosin and Masson-trichrome staining.</p> <p>Results</p> <p>In total, 38 subjects underwent EMI with a surgical (n = 17) or endovascular (n = 21) approach. ST-segment elevation (1.90 ± 0.71 mm) occurred sharply after surgical LAD ligation compared to progressive ST elevation (2.01 ± 0.84 mm;p = 0.68) within 15-20 min after LAD micro-coil embolization. Increase of troponin and other cardiac enzymes, abnormal ischemic Q waves and LVEDP changes were recorded in both groups without any significant differences (p > 0.05). Infarct area was similar in both models (0.86 ± 0.35 cm in the surgical group vs. 0.92 ± 0.54 cm in the percutaneous group;p = 0.68).</p> <p>Conclusion</p> <p>The proposed model of transauricular coronary coil embolization avoids thoracotomy and major surgery and may be an equally reliable and reproducible platform for the experimental study of myocardial ischemia.</p

    Multi-modality curative treatment of salivary gland cancer liver metastases with drug-eluting bead chemoembolization, radiofrequency ablation, and surgical resection: a case report

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    <p>Abstract</p> <p>Introduction</p> <p>Liver metastases are rare in salivary gland tumors and have been reported only once to be the first manifestation of the disease. They are usually treated with surgical resection of the primary tumor and systemic chemotherapy. Drug-eluting bead chemoembolization has an evolving role in the treatment of hepatocellular carcinoma, as well as in the treatment of metastatic disease of the liver. Nevertheless, it has never been used in a patient with salivary gland liver metastases.</p> <p>Case presentation</p> <p>We report a case of a 51-year-old Caucasian Greek woman who presented to our hospital with liver metastases as the first manifestation of an adenoid cystic carcinoma of the left submandibular gland. The liver lesions were deemed inoperable because of their size and multi-focality and proved resistant to systemic chemotherapy. She was curatively treated with a combination of doxorubicin eluting bead (DC Beads) chemoembolization, intra-operative and percutaneous radiofrequency ablation, and radiofrequency-assisted surgical resection. The patient remained disease-free one year after the surgical resection.</p> <p>Conclusion</p> <p>In conclusion, this complex case is an example of inoperable liver metastatic disease from the salivary glands that was refractory to systemic chemotherapy but was curatively treated with a combination of locoregional therapies and surgery. A multi-disciplinary approach and the adoption of modern radiological techniques produced good results after conventional therapies failed and there were no other available treatment modalities.</p
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