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

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

Below-the-ankle Angioplasty: Current Evidence and Future Perspectives

Over 20 million adults in Europe suffer from peripheral arterial disease (PAD). The annual incidence of PAD is approximately 2.4%, while the annual incidence of critical limb ischaemia (CLI), the last and most severe stage of PAD, has been reported to be 0.4%. Endovascular angioplasty and/or stenting of infrapopliteal disease is, today, an established treatment for critical limb ischaemia. The main technical advantages of endovascular treatment over open bypass surgery include the possibility to revascularise more than one infrapopliteal vessels and, most importantly, to treat outflow pedal vessel disease or even reconstitute the pedal arch. Data of below-the-ankle angioplasty are beginning to sum up and the contribution of pedal arch angioplasty in limb salvage and wound healing are currently under investigation. In this review, currently available data and the future perspectives on below-the-ankle and pedal arch endovascular treatment will be presented

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

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

Long-term outcomes of CT-guided percutaneous cryoablation of T1a and T1b renal cell carcinoma

PURPOSEWe aimed to evaluate the long-term outcomes of computed tomography-guided percutaneous cryoablation (PCA) for biopsy-confirmed renal cell carcinoma (RCC).METHODSThis was a single-center, retrospective study investigating all patients treated with PCA between January 2010 and February 2019 for RCC tumors. Primary outcome measures included overall survival (OS), disease-free survival (DFS), progression-free survival (PFS) and cancer-specific survival (CSS). Secondary outcome measures included kidney function, complications, technical success, hospital stay, procedural time, and the identification of factors affecting the primary outcomes.RESULTSFifty-three consecutive patients with 54 lesions (T1a: 49/54; T1b: 5/54) were included. Mean tumor diameter was 28.0±8.5 mm and mean R.E.N.A.L. score was 7.2±2.0. Technical success was 100% (54/54 lesions) after two reinterventions for incomplete ablation. Mean follow-up time was 46.7±28.6 months (range, 3–122 months). Local recurrence was noted in 5 patients (9.2%). According to Kaplan-Meyer analysis, OS was 98.2%, 94.2%, 71.2%, and 58.2% at 1, 3, 5, and 8 years. One patient (1.9%) died of cancer and CSS was 95.8% at 8 years. DFS was 100.0%, 95.5%, and 88.6%, and PFS was 100%, 94.3%, and 91.0%, at 1, 2, and 5 years. Clavien–Dindo grade II complication rate was 7.8% (5/64 procedures). There were no complications classified as grade III or greater. Mean creatinine increase was 7.1±6.3 μm/L (p = 0.31). No patient advanced to dialysis during follow up. Mean procedural time was 163±45 min. Median hospital stay was 2.0 days (IQR, 1–2.5 days). Diabetes was the only independent predictor of decreased OS (hazard ratio 4.3, 95% CI 0.043–0.914; p = 0.038).CONCLUSIONPCA for stage T1a and T1b RCC provides favorable long-term oncological and renal function preservation outcomes, with acceptable complication rates

Emerging Stent and Balloon Technologies in the Femoropopliteal Arteries

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

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

Endovascular Treatment for Acute Basilar Artery Occlusion: A Fragility Index Meta-Analysis

Introduction: High-quality evidence regarding the use of endovascular treatment (EVT) in patients with acute basilar artery occlusion (BAO) has been provided by recently completed randomized controlled clinical trials (RCTs). Methods: We conducted a systematic review and meta-analysis including all available RCTs that investigated efficacy and safety of EVT in addition to best medical treatment (BMT) versus BMT alone for BAO. The random-effects model was used, while the fragility index (FI) was calculated for dichotomous outcomes of interest. Results: Four RCTs were included comprising a total of 988 patients with acute BAO (mean age: 65.6 years, 70% men, median NIHSS: 24, 39% pretreatment with intravenous thrombolysis). EVT was related to higher likelihood of good functional outcome (RR: 1.54; 95% CI: 1.16–2.05; I2 = 60%), functional independence (RR: 1.83; 95% CI: 1.08–3.08; I2 = 79%) and reduced disability at 3 months (adjusted common OR: 1.96; 95% CI: 1.26–3.05; I2 = 59%) compared to BMT alone. Despite that EVT was associated with a higher risk for symptomatic intracranial hemorrhage (RR: 7.78; 95% CI: 2.36–25.61; I2 = 0%) and any intracranial hemorrhage (RR: 2.85; 95% CI: 1.50–5.44; I2 = 16%), mortality at 3 months was lower among patients that received EVT plus BMT versus BMT alone (RR: 0.76; 95% CI: 0.65–0.89; I2 = 0%). However, sufficient robustness was not evident in any of the reported associations (FI < 10) including the overall effect regarding the primary outcome. The former associations were predominantly driven by RCTs with recruitment limited in China. Conclusions: EVT combined with BMT is associated with a higher likelihood of achieving good functional outcomes and a lower risk of death at 3 months compared to BMT alone, despite the higher risk of sICH. An individual-patient data meta-analysis is warranted to uncover and adjust for potential sources of heterogeneity and to provide further insight

Possible use of Digital Variance Angiography in Liver Transarterial Chemoembolization: A Retrospective Observational Study

Purpose Digital variance angiography (DVA), a recently developed image processing technology, provided higher contrast-to-noise ratio (CNR) and better image quality (IQ) during lower limb interventions than digital subtraction angiography (DSA). Our aim was to investigate whether this quality improvement can be observed also during liver transarterial chemoembolization (TACE).Materials and MethodsWe retrospectively compared the CNR and IQ parameters of DSA and DVA images from 25 patients (65% male, mean +/- SD age: 67.5 +/- 11.2 years) underwent TACE intervention at our institute. CNR was calculated on 50 images. IQ of every image set was evaluated by 5 experts using 4-grade Likert scales. Both single image evaluation and paired image comparison were performed in a blinded and randomized manner. The diagnostic value was evaluated based on the possibility to identify lesions and feeding arteries.ResultsDVA provided significantly higher CNR (mean CNRDVA/CNRDSA was 1.33). DVA images received significantly higher individual Likert score (mean +/- SEM 3.34 +/- 0,08 vs. 2.89 +/- 0.11, Wilcoxon signed-rank p &lt; 0.001) and proved to be superior also in paired comparisons (median comparison score 1.60 [IQR:2.40], one sample Wilcoxon p &lt; 0.001 compared to equal quality level). DSA could not detect lesion and feeding artery in 28 and 36% of cases, and allowed clear detection only in 22% and 16%, respectively. In contrast, DVA failed only in 8 and 18% and clearly revealed lesions and feeding arteries in 32 and 26%, respectively.ConclusionIn our study, DVA provided higher quality images and better diagnostic insight than DSA; therefore, DVA could represent a useful tool in liver TACE interventions

Intra-abdominal hypertension due to heparin - induced retroperitoneal hematoma in patients with ventricle assist devices: report of four cases and review of the literature

<p>Abstract</p> <p>Introduction</p> <p>Elevated intra-abdominal pressure (IAP) has been identified as a cascade of pathophysiologic changes leading in end-organ failure due to decreasing compliance of the abdomen and the development of abdomen compartment syndrome (ACS). Spontaneous retroperitoneal hematoma (SRH) is a rare clinical entity seen almost exclusively in association with anticoagulation states, coagulopathies and hemodialysis; that may cause ACS among patients in the intensive care unit (ICU) and if treated inappropriately represents a high mortality rate.</p> <p>Case Presentation</p> <p>We report four patients (a 36-year-old Caucasian female, a 59-year-old White-Asian male, a 64-year-old Caucasian female and a 61-year-old Caucasian female) that developed an intra-abdominal hypertension due to heparin-induced retroperitoneal hematomas after implantation of ventricular assist devices because of heart failure. Three of the patients presented with dyspnea at rest, fatigue, pleura effusions in chest XR and increased heart rate although b-blocker therapy. A 36-year old female (the forth patient) presented with sudden, severe shortness of breath at rest, 10 days after an "acute bronchitis". At the time of the event in all cases international normalized ratio (INR) was <3.5 and partial thromboplastin time <65 sec. The patients were treated surgically, the large hematomas were evacuated and the systemic manifestations of the syndrome were reversed.</p> <p>Conclusion</p> <p>Identifying patients in the ICU at risk for developing ACS with constant surveillance can lead to prevention. ACS is the natural progression of pressure-induced end-organ changes and develops if IAP is not recognized and treated in a timely manner. Failure to recognize and appropriately treat ACS is fatal while timely intervention - if indicated - is associated with improvements in organ function and patient survival. Means for surgical decision making are based on clinical indicators of adverse physiology, rather than on a single measured parameter.</p

Cryoplasty: in vivo investigation in an experimental rabbit arterial model and clinical study in the superficial femoral artery of diabetic patients suffering from peripheral arterial disease

Peripheral obstructive arterial disease (PAOD) represents a pathology affecting over 20 million people in Europe and diabetes mellitus (DM) has been long recognized as an independent risk factor of PAOD. The main artery affected by the disease is the femoropopliteal axis, which constitutes a particularly hostile territory, regarding the percutaneous endovascular treatment, due to the disappointedly high percentages of restenosis and clinically driven repeated procedures. Cryoplasty has been proposed as a novel method of endovascular treatment of the femoropopliteal axis, with acceptable initial results. This particular scientific research was aiming in the clinical investigation of the immediate and long term results of the commercially available cryoplasty system in the femoropopliteal artery of patients suffering from DM, as well as the study of cryoplasty application in an experimental in vivo animal model, compared to conventional balloon angioplasty (COBA). This double scientific protocol reported the first long-term angiographic and clinical data, regarding the randomized comparison of cryoplasty and COBA in the specific anatomical region and also the first results from the direct comparison of the single and double PolarCath application versus a conventional balloon catheter, in an in vivo arterial animal model. Cryoplasty was not proven superior to COBA, as the multivariable Cox statistical model detected cryoplasty as an independent predictor of reduced primary patency and elevated repeated clinically driven procedures, while the bivariable Kaplan-Meyer estimated significantly higher restenosis rate in the cryoplasty group, up to 3 years follow-up. On the other hand, the results from the in vivo application of cryoplasty detected superior smooth muscle cells (SMC) apoptotic rates, compared to the control group. The double application of cryoplasty on the arterial wall was safe as it resulted in low grade arterial barotrauma and inflammation scores. However, the double application of cryoplasty was not able to induce superior rates of apoptosis of the SMC, compared to the single application. The results herein reported, suggest that although cryoplasty can be considered a safe and minimally traumatic method of angioplasty, which induces apoptosis and not necrosis of the SMC, the optimization of the system is fundamental, in order to be further applied in every day clinical practice.Περισσότεροι από 20 εκατομμύρια άνθρωποι στην Ευρώπη πάσχουν από περιφερική αποφρακτική αρτηριοπάθεια των κάτω άκρων (ΠΑΑΚΑ) και ο σακχαρώδης διαβήτης αποτελεί πλέον διαπιστωμένα έναν από τους ανεξάρτητους παράγοντες κινδύνου της νόσου. Ο μηριαίο-ιγνυακός άξονας είναι γνωστός ως μια ιδιαίτερα “εχθρική” ανατομική περιοχή, όσον αφορά στην ενδαγγειακή αντιμετώπιση της ΠΑΑΚΑ, καθώς παρά τα υψηλά ποσοστά άμεσης τεχνικής επιτυχίας, παρουσιάζει επίσης υψηλά ποσοστά κλινικής υποτροπής και επανεπεμβάσεων λόγω του φαινομένου της επαναστένωσης. Η κρυοπλαστική έχει προταθεί ως μια νέα μέθοδος αντιμετώπισης της ΠΑΑΚΑ του μηριαίο-ιγνυακού άξονα, παρουσιάζοντας ικανοποιητικά αρχικά αποτελέσματα. Σκοπός της συγκεκριμένης ερευνητικής εργασίας ήταν τόσο η κλινική μελέτη των άμεσων και μακροχρόνιων αποτελεσμάτων της εμπορικά διαθέσιμης κρυοπλαστικής, όσον αφορά στην αντιμετώπιση της ΠΑΑΚΑ του μηριαίο-ιγνυακού άξονα διαβητικών ασθενών, όσο και η πειραματική εφαρμογή της σε in vivo αρτηριακό μοντέλο κονίκλων, συγκριτικά με την συμβατική αγγειοπλαστική. Το διπλό αυτό επιστημονικό πρωτόκολλο, απέφερε τα πρώτα μακροχρόνια αγγειογραφικά και κλινικά δεδομένα της τυχαιοποιημένης σύγκρισης μεταξύ της κρυοπλαστικής και της συμβατικής αγγειοπλαστικής στην συγκεκριμένη ανατομική περιοχή, καθώς και τα πρώτα in vivo αποτελέσματα της σύγκρισης των δύο μεθόδων, αλλά και της διπλής εφαρμογής της κρυοπλαστικής στο αρτηριακό τοίχωμα. Τα κλινικά αποτελέσματα δεν επαλήθευσαν την ανωτερότητα της κρυοπλαστικής έναντι της συμβατικής αγγειοπλαστικής, καθώς η πολύπαραγοντική Cox ανάλυση ανίχνευσε μεγαλύτερο ποσοστό κινδύνου όσον αφορά στην απώλεια της πρωτογενούς βατότητας και στην διενέργεια επανεπεμβάσεων, ενώ η διωνυμική Kaplan-Meyer ανάλυση προέβλεψε σημαντικά μεγαλύτερο ποσοστό επαναστένωσης στα 3 έτη. Εν αντιθέσει, τα αποτελέσματα του πειραματικού πρωτοκόλλου εξακρίβωσαν μεγαλύτερα ποσοστά απόπτωσης των λείων μυϊκών κυττάρων του μέσου χιτώνα στην ομάδα της κρυοπλαστικής, συγκριτικά με την συμβατική αγγειοπλαστική. Επίσης η διπλή εφαρμογή της κρυοπλαστικής απεδείχθη ασφαλής, με χαμηλό βαθμό αρτηριακού τραυματισμού και φλεγμονής. Παρά ταύτα η διπλή εφαρμογή δεν απέφερε ποσοτική αύξηση της απόπτωσης των λείων μυϊκών κυττάρων του μέσου χιτώνα, συγκριτικά με την μονή εφαρμογή. Τα αποτελέσματα της συγκεκριμένης επιστημονικής εργασίας οδηγούν στο συμπέρασμα ότι πράγματι η κρυοπλαστική αποτελεί μια ελάχιστα τραυματική μέθοδο αγγειοπλαστικής, η οποία επάγει την απόπτωση των λείων μυϊκών κυττάρων, χωρίς να προκαλεί νέκρωση των κυτταρικών στοιχείων του αρτηριακού τοιχώματος, αλλά η βελτιστοποίηση του συστήματος αποτελεί αναγκαιότητα για την περαιτέρω κλινική της εφαρμογή