Carlo Cirelli

Lower Limb Multilevel Treatment With Drug-Eluting Balloons: 6-Month Results From the DEBELLUM Randomized Trial:

Purpose To report 6-month results of the DEBELLUM (Drug-Eluting Balloon Evaluation for Lower Limb MUltilevel TreatMent) randomized trial to evaluate the efficacy of a drug-eluting balloon (DEB) to reduce restenosis after treatment of multilevel lower limb occlusive disease vs. a conventional angioplasty balloon (AB). Methods Between September 2010 and March 2011, 50 consecutive patients (37 men; mean age 66 ± 4 years) with 122 lesions (96 stenoses and 26 occlusions) of the femoropopliteal (92, 75.4%) or below-the-knee (BTK) arteries (30, 24.6%) were enrolled and randomly assigned to the DEB (25 patients with 57 lesions) or AB (25 patients with 65 lesions) group. Twenty patients presented multilevel lesions. Mean lesion length was 7.5 ± 3.5 cm. Thirty-one (62%) of the patients were Fontaine stage IIb, while 19 (38%) were stage III or IV. DEBs or ABs were used for dilation of de novo lesions or for postdilation after primary stenting (superficial femoral artery only). Patients requiring provisional stenting after angioplasty secondary to flow-limiting dissection or residual stenosis >50% were ineligible. Primary endpoint was late lumen loss at 6 months. Secondary endpoints were target lesion revascularization (TLR), amputation, and thrombosis. Results Late lumen loss was lower in the DEB group (0.5 ± 1.4 vs. 1.6 ± 1.7 mm, p<0.01). TLR was necessary in 6.1% of the DEB group vs. 23.6% of the AB group (p=0.02). Comparing the DEB to AB groups, the thrombosis rates were 3.0% vs. 5.2% (p=0.6), and the amputation rates were 3.0% vs. 7.9% (p=0.36). The binary restenosis rates were 9.1% (3/33 limbs) in the DEB group vs. 28.9% (11/38 limbs) in the control group (p=0.03). The anklebrachial index improved to a greater degree in the DEB group: 0.87 ± 0.22 vs. 0.70 ± 0.13 (p<0.05). The Fontaine stage improved in both groups but more so in patients treated with DEBs (p=0.04). Conclusion The DEBELLUM trial confirmed the ability of paclitaxel-eluting balloons to reduce restenosis vs. conventional balloons at 6 months after treatment of multilevel (femoropopliteal and BTK) arterial disease in patients affected by claudication and CLI. A lower TLR rate and better clinical outcomes appear to be associated with the use of DEBs regardless of stent placement.

Minimally invasive treatment of gastric leak after sleeve gastrectomy

PurposeObesity is a leading problem in Western countries, and laparoscopic sleeve gastrectomy (SG) is the most commonly used procedure for the surgical management of morbid obesity. SG is recognised as one of the safest and most effective bariatric procedures but it is limited by a rate of gastric leaks (GL) ranging from 1.4% to 20%. No international consensus exists about the treatment of GL. This paper reports our experience with the noninvasive management of GL.Materials and methodsFrom July 2004 to December 2010, 16 patients with GL after SG were referred to our unit. All patients underwent contrast radiography (Gastrografin) and computed tomography (CT) examination. On the basis of the radiographic findings, patients were divided into those eligible for drainage and those not eligible.ResultsTwelve patients (75%) were eligible for percutaneous drainage. Of these, seven patients (44%) were successfully treated with percutaneous drainage alone, whereas five patients (31%) required placement of a covered stent due to incomplete resolution of the collection. After 1009.8±456.7 days of follow-up, one patient died from a cardiovascular event and two patients required a bilio-pancreatic-digestive bypass (BPD-BP). Twelve patients (75%) were in an excellent state of health with significant reduction of their body mass index (BMI).ConclusionsOur experience confirms the value of an algorithm based on patient eligibility for percutaneous drainage in the treatment of GL. The patient’s general condition and in particular the presence of sepsis supports the value of this approach in preference to the conventional surgical approach.RiassuntoObiettivoL’obesità è uno dei problemi emergenti dei paesi industrializzati e la sleeve gastrectomy (SG) è una dei presidi più utilizzati per la cura dell’obesità patologica. La SG è riconosciuta come una delle più sicure tecniche chirurgiche bariatriche, ma è gravata in percentuale variabile dall’1,4% al 20% da fistola gastrica (GL). Non esiste un consensus internazionale sul trattamento del GL dopo SG. Riportiamo la nostra esperienza nel trattamento minimamente invasivo del GL dopo SG.Materiali e metodiDa giugno 2004 a gennaio 2010, 16 pazienti con GL post SL sono stati trattati dal nostro team. Tutti i pazienti sono stati sottoposti a transito con mezzo di contrasto per os (Gastrografin) e tomografia computerizzata (CT). In base all’aspetto radiografico i pazienti sono stati suddivisi in passibili di drenaggio e non passibili di drenaggio.RisultatiDodici pazienti (75%) sono stati passibili di drenaggio. Di questi in 7 (44%) pazienti il drenaggio percutaneo è stato l’unico presidio terapeutico; 5 pazienti (31%) hanno richiesto stents per la mancata risoluzione del GL. Dopo 1009,8±456,7 giorni di follow-up: 1 paziente è morto per evento cardiovascolare e 2 pazienti sono stati sottoposti a bypass bilio-pancreatico-digestivo. 12 pazienti (75%) presentano un ottimo stato di salute con riduzione dell’indice di massa corporea (BMI).ConclusioniLa nostra esperienza conferma l’utilizzo di un algoritmo basato sulla fattibilità del drenaggio percutaneo per la cura del GL. La presenza di sepsi corrobora questo approccio rispetto al tradizionale trattamento chirurgico.

Endovascular Repair of Acute and Chronic Aortic Type B Dissections: Main Factors Affecting Aortic Remodeling and Clinical Outcome.

OBJECTIVES The aim of this study was to assess factors influencing the clinical outcome and morphological changes of acute and chronic type B aortic dissection after thoracic endovascular aortic repair (TEVAR). BACKGROUND Aortic remodeling after TEVAR may be associated with clinical outcome, complications, and endoleak development. METHODS Sixty cases of TEVAR for complicated type B acute aortic dissection (AAD) (n = 29) and chronic aortic dissection (CAD) (n = 31) with a minimum follow-up of 3 years were retrospectively reviewed. Using computed tomography images, we assessed true lumen, false lumen, and total aortic short-axis diameters. Six procedural factors were analyzed in relation to aortic remodeling and other outcomes. Analysis of variance was used to compare short-axis, false lumen, and true lumen diameters during the follow-up period. Univariate and multivariate analyses were used to assess the relationship between procedural factors and multiple outcomes. RESULTS A total of 100 stent grafts were implanted in 60 consecutive patients with acute aortic dissection (AAD) and CAD. Aortic remodeling consisting of false lumen thrombosis and shrinkage was more prominent in AAD than in CAD, especially within the first 18 months. Of note, the entire aortic diameter increased significantly cephalad to the stent graft in AAD. Only in the AAD group there was increased aortic remodeling related to post-dilation of the stent graft. Type I and II endoleaks occurred in 17 patients (28%); in AAD, embolization of the left subclavian artery after stent graft deployment was significantly associated with a lower risk of endoleak development, but this was not evident in CAD. CONCLUSIONS Aortic remodeling and clinical outcome after TEVAR can be influenced by procedural techniques (post-dilation and embolization of the left subclavian artery in patients with acute but not chronic aortic dissection).

Femoral Artery Ultrasound Examination: A New Role in Predicting Cardiovascular Risk

We compared intima–media thickness (IMT) and the prevalence of plaques in the common carotid artery (CCA) and common femoral artery (CFA) in apparently healthy participants. This multicenter study included 322 participants (59.9% female; age 20-78 years, mean 52.1 ± 15.3 years) who underwent Echo-color Doppler examination of the CCA and CFA bilaterally. Prevalence and composition of plaque were recorded. A significant (P < .01) difference between mean CCA-IMT and mean CFA-IMT was detected (0.70 vs 0.73 mm). Plaque prevalence was significantly higher in the CFA compared to the CCA (40.7% vs 30.4%). Atherosclerotic plaques were found in both CFA and CCA in 46% of the cases, solely in CFA in 38%, and in CCA alone in 17%. The observed difference in plaque prevalence was even greater when only fibrolipid isolated plaques were considered (CFA 39.4% vs CCA 22.1%). In a healthy general population, atherosclerotic plaques were present in the CFA but not in the CCA in over one-third of the cases. Further studies must confirm whether ultrasonography of the CFA might be introduced in the screening protocols for cardiovascular risk assessment.

Endovascular treatment of hepatocellular carcinoma with drug eluting microparticles (DC-Beads): CT evaluation of response to the treatment

Background and Study Aims: Our aim was to assess the efficacy and tolerability of drug-eluting beads-transarterial chemoembolization (DEB-TACE) in the treatment of hepatocellular carcinoma (HCC), evaluating the response to the treatment after 1, 6, 12, and 24 months with multidetector computed tomography (MDCT) comparing European Association for the study of the Liver (EASL) and modified Response Evaluation Criteria in Solid Tumors (mRECIST) criteria. Materials and Methods: We enrolled 154 patients with uni- or multifocal HCC who underwent a DEB-TACE. A total of 278 HCC nodules were treated. CT follow-up was performed at 1, 6, 12, and 24 months after the procedure according to the EASL and RECIST criteria evaluating overall target and target nodule response. We also analyzed the shrinking of nodules in relation to response to treatment. Results: A total of 278 nodules of HCC underwent TACE by using DC-Beads: At 24, months complete response was similar for EASL and RECIST criteria (112 vs. 121 nodules) with optimal accordance between methods and readers with k = 0.9. Partial Response resulted significantly different among the two methods within the first month, otherwise was similar after 24-month follow-up. Similar results in both methods were found for nodules classified as Stable Disease (P > 0.05). Progressive Disease results were similar in both the groups according to both the classification criteria without any significant difference (P > 0.05). Conclusion: Our study confirmed that EASL and mRECIST criteria are both effective methods for patient follow-up, however with some technical differences.

Carotid artery stenting: analysis of a 12-year single-center experience.

Purpose To analyze a 12-year experience performing carotid artery stenting (CAS) with cerebral protection. Methods In accord with NASCET criteria, 672 patients underwent CAS at our hospital between November 1999 and September 2011 for de novo or postsurgical restenosis; among these, 636 patients (474 men; mean age 68 ± 6.8 years, range 63–85) had a minimum 6-month follow-up, which qualified them for this analysis. The majority of patients (381, 59.9%) were symptomatic; 47 patients had staged bilateral CAS procedures (total of 683 procedures). A cerebral protection device was used in 94.7%. Patients underwent duplex ultrasound and clinical evaluation during follow-up. Neurological adverse events were correlated with plaque morphology, patient age >80 years, learning curve, and spasm. Results Technical success was achieved in all cases. Neurological events [3 (0.4%) major strokes, 8 (1.2%) minor strokes, and 11 (1.6%) transient ischemia attacks] occurred in 22 (3.2%) of the 683 cases within 30 days of the procedure (no events in follow-up). These involved 5 (2.0%) of the 255 asymptomatic patients and 17 (4.5%) of the 381 symptomatic patients (p=0.001). Neurological events proved to be higher in patients >80 years (6.4% vs. 2.7% of patients <80 years, p<0.05) and in those with complex plaque morphology (6.1% vs. 1.0% in stable plaques, p<0.001). After a mean follow-up of 76 ± 32.4 months, 478 (70%) patients were alive, with a 30-day mortality of 1.9% (none due to stroke). In-stent stenosis occurred in 9 (1.3%) stents and was resolved with angioplasty or re-stenting. The primary patency rate was 98.7%. Conclusion CAS is a valid technique for the treatment of carotid occlusive disease, with a very low rate of in-stent stenosis. Neurological complications were correlated with complex plaque morphology, which makes accurate pretreatment evaluation of the lesion mandatory if good CAS outcomes are to be achieved.

Comparison of Image Quality and Diagnostic Performance of Cone-Beam CT during Drug-Eluting Embolic Transarterial Chemoembolization and Multidetector CT in the Detection of Hepatocellular Carcinoma

PURPOSE To compare image quality and diagnostic performance of cone-beam computed tomography (CT) and multidetector CT in the detection of hypervascular hepatocellular carcinoma (HCC) in patients with cirrhosis undergoing transarterial chemoembolization with drug-eluting embolic agents. MATERIALS AND METHODS Fifty-five consecutive patients referred for chemoembolization of hypervascular HCC were prospectively enrolled. Imaging included preprocedural multidetector CT within 1 month before planned treatment, intraprocedural cone-beam CT, and 1-month follow-up multidetector CT. Analysis of image quality was performed with calculations of lesion-to-liver contrast-to-noise ratio (LLCNR) and lesion-to-liver signal-to-noise-ratio (LLSNR). One-month follow-up multidetector CT was considered the reference standard for the detection of HCC nodules. RESULTS Median LLCNR values were 3.94 (95% confidence interval [CI], 3.06-5.05) for preprocedural multidetector CT and 6.90 (95% CI, 5.17-7.77) for intraprocedural cone-beam CT (P < .0001). Median LLSNR values were 11.53 (95% CI, 9.51-12.44) for preprocedural multidetector CT and 9.36 (95% CI, 8.12-10.39) for intraprocedural cone-beam CT (P < .0104). Preprocedural multidetector CT detected 115 hypervascular nodules with typical HCC behavior, and cone-beam CT detected 15 additional hypervascular nodules that were also visible on 1-month follow-up multidetector CT. CONCLUSIONS Cone-beam CT has a significantly higher diagnostic performance compared with preprocedural multidetector CT in the detection of HCCs and can influence management of patients with cirrhosis by identifying particularly aggressive tumors.

Angioseal VIP® vs. Starclose SE® closure devices: a comparative analysis in non-cardiological procedures.

BACKGROUND The aim of this paper was to compare the use of two different commercially available vascular closure devices (VCD), Angioseal VIP® (St. Jude Medical, St. Paul, MN, USA) and StarClose SE (Abbott Laboratories, Abbott Park, IL, USA). METHODS From January 2010 to January 2012, 347 patient underwent retrograde femoral arterial puncture for different interventional procedures (angioplasty, stenting, embolization for bleeding, fibrinolysis for ischemia and chemoembolization). Hemostasis was achieved by deployment of an Angioseal VIP® (N.=184) or StarClose SE® (N.=163). In 94 cases, the retrograde femoral access was bilateral and managed with two StarClose SE devices (N.=53) or an Angioseal VIP® plus a StarClose SE® (N.=41). RESULTS Technical success was obtained in 95.1% (330/347) of patients. Overall time to hemostasis (TTH) and time to ambulation (TTA) were 5,5±1,5 min (range 3-8 min) and 6±2.5 hr (range 2-9 hours) respectively. No statistical significative difference (P>0.05) were appreciable between to groups for both TTH and TTA: Angioseal VIP® TTH was 5.3±1.4 min and StarClose SE® TTH was 5.6±1.6 min; Angioseal VIP® TTA was 5.9±1.8 hr and StarClose SE® TTA was 6.1±1.9 hr. VAS scores result underline a mild difference between two devices. Angioseal VIP® patients experience a mild to moderate pain within the first 3 minutes from the deployment. Whereas StarClose SE® patients still experience pain at 5 minutes from deployment. The device failure rate was 4.9% (17 cases) and included 13 minor complications and 4 major complications. Minor complications (3.75%) occurred during the initial phase and consisted in recurrent wound bleeding (N.=5 StarClose SE®; N.=4 Angioseal VIP®) treated with manual compression, and hematoma (N.=2 StarClose SE®; N.=2 Angioseal VIP®) that solved spontaneously. The 4 major complications (1,15%) were: 1 Angioseal-related common femoral artery (CFA) obstruction treated with surgical bypass from the CFA to the superficial femoral artery; 1 Angioseal-related CFA dissection solved with surgery; 1 Angioseal-related embolization of the deep femoral artery partially treated with localized fibrinolysis; 1 StarClose-related pseudoaneurysm treated with manual compression. CONCLUSIONS Both Angioseal VIP® and StarClose SE® systems can be considered safe and effective in providing hemostasis following a variety of interventional vascular procedures.

Vertebral Artery Diameter and Flow: Nature or Nurture

In contrast with the carotid arteries, the vertebral arteries (VAs) show considerable variation in length, caliber, and vessel course. This study investigated whether the variation in diameter and flow characteristics of the VAs might be inherited.

Genetic influence on femoral plaque and its relationship with carotid plaque: an international twin study

To disentangle genetic and environmental influences on the development of femoral plaques using a population of adult twins. To evaluate the potential role of shared genetic and environmental factors in the co-occurrence of femoral and carotid plaques. The sample included 566 twins belonging to 164 monozygotic (MZ) and 119 dizygotic (DZ) twin pairs, who underwent peripheral arterial assessment by B-mode ultrasound in different centers. The variance in femoral plaques onset was due to genetic factors and the remaining 50% was explained by common (15%) and unique (35%) environmental factors. Findings on sidedness and number of femoral plaques indicated that also these traits were mainly under genetic control. No effect of common environment was found on plaques composition, and variability of this trait was explained by genetics (64%) and unique environment (36%). Covariation between the liabilities to carotid and femoral plaques was mainly attributed to shared genes (77%), with the remaining 23% explained by individual-specific environmental factors shared by the two districts. Inter-individual differences in plaque onset as well as in their number, sidedness and composition are mainly genetic in origin. The results on the cooccurrence of carotid and femoral plaque underline the genetic role in atherogenesis.