Mario Corona

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.

Retrograde popliteal access in the supine patient for recanalization of the superficial femoral artery: initial results.

Purpose To report an initial experience of superficial femoral artery (SFA) recanalization performed with a dual femoral-popliteal approach in the supine patient. Methods From May 2008 to April 2010, 26 patients (16 men; mean age 68±6.3 years) with intermittent claudication and chronic SFA occlusion (mean length 97.4±3.8 mm, range 35–220) underwent percutaneous recanalization from a retrograde popliteal access. The common femoral artery was punctured with an antegrade (n=9) or retrograde contralateral (n=17) approach, then with the patient still supine and the knee gently flexed and medially rotated, the popliteal artery was punctured using an 18-G needle under ultrasound (10, 38.4%) or fluoroscopic (16, 61.5%) guidance with a roadmap technique. Once the SFA was recanalized, the procedure was completed with angioplasty and stenting from the femoral approach. At the end of the procedure, hemostasis at the popliteal access was obtained with manual compression (5–10 minutes). Results Technical success (puncture of the popliteal artery and SFA recanalization) was achieved in all cases. In the majority of patients (24, 91.6%), endoluminal recanalization was possible from the popliteal access; SFA recanalization in the other 2 cases was obtained through the subintimal space. Two small hematomas were found in the popliteal region, but no pseudoaneurysm or arteriovenous fistulas were seen on duplex examinations during a mean 12.5-month follow-up (range 6–28). Twenty (76.9%) SFAs were patent; in-stent restenosis occurred in the remaining 6 (23%). Primary patency was 80.7% at 6 months and 76.9% at 1 year. No stent fracture was observed. Conclusion The retrograde popliteal approach with the patient in the supine position can be considered a “first choice” method for safe and effective SFA recanalization, especially in occlusions located at the distal and mid portion SFA.

Complete transection of the main bile duct: minimally invasive treatment with an endoscopic-radiologic rendezvous

BACKGROUND Complete transection of the common bile duct (CBD) is a dramatic and often extremely difficult-to-repair event after surgery. Abdominal biliary fluid collection or jaundice is the initial symptom, and ERCP is the determinant for diagnosis. OBJECTIVE To evaluate the safety and efficacy of a combined endoscopic-radiologic technique for the reconstruction of the CBD. DESIGN Single-center retrospective study. SETTING Tertiary-care center for biliary surgery. PATIENTS This study involved 22 patients with complete transection of the CBD after cholecystectomy. INTERVENTION A guidewire is passed in the subhepatic space through the endoscopic approach. A snare loop is advanced from the percutaneous entry site to catch the free end of the wire and then pulled outside the body: a percutaneous biliary-duodenal (PTBD) drainage is put in place. After a new contralateral PTBD, 4 plastic stents are inserted. The stents are removed endoscopically after 8 to 12 months. MAIN OUTCOME MEASUREMENTS Success of the rendezvous maneuver, patient recovery, and patient mortality. RESULTS After a mean follow-up period of 4 years, 16 patients are asymptomatic. Two patients are still under treatment, and 4 patients underwent surgery, as was the surgeons choice. LIMITATIONS Single-center, retrospective study with a small population. CONCLUSION Interruption of the biliary tree does not represent an indication for an often-difficult surgical treatment, because the CBD is often thin in the presence of biliary peritonitis. However, the condition can be treated with a rendezvous technique. Surgery can be performed in elective conditions or completely avoided when conservative therapy is selected.

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.

Traumatic subclavian arterial rupture: a case report and review of literature

Subclavian artery injuries represent an uncommon complication of blunt chest trauma, this structure being protected by subclavius muscle, the clavicle, the first rib, and the deep cervical fascia as well as the costo-coracoid ligament, a clavi-coraco-axillary fascia portion. Subclavian artery injury appears early after trauma, and arterial rupture may cause life-treatening haemorrages, pseudo-aneurysm formation and compression of brachial plexus. These clinical eveniences must be carefully worked out by accurate physical examination of the upper limb: skin color, temperature, sensation as well as radial pulse and hand motility represent the key points of physical examination in this setting. The presence of large hematomas and pulsatile palpable mass in supraclavicular region should raise the suspicion of serious vascular injury. Since the first reports of endovascular treatment for traumatic vascular injuries in the 90’s, an increasing number of vascular lesions have been treated this way. We report a case of traumatic subclavian arterial rupture after blunt chest trauma due to a 4 meters fall, treated by endovascular stent grafting, providing a complete review of the past twenty years’ literature.

Impact of 3D Rotational Angiography on Liver Embolization Procedures: Review of Technique and Applications

AbstractIn the last years, the interest into interventional applications of C-arm cone-beam CT (CBCT) progressively raised, widening its clinical application from the original field of interventional neuroradiology to the field of peripheral procedures. Liver embolization procedures, due to their complexity and potential treatment-related life-threatening complications, represent one of the main clinical applications of this novel angiographic technique. CBCT has been demonstrated to render procedures safer and technically easier, and to predict outcome as well as to avoid major complications in different treatment scenarios (trans-arterial embolization, trans-arterial chemoembolization, selective internal radiation therapy, percutaneous portal vein embolization). This review summarizes all technical, dosimetric and procedural aspects of CBCT techniques, underlying all its potential clinical advantages in the field of liver embolization procedures. Moreover, the paper provides all the instructions to obtain the best diagnostic performance out of this novel angiographic technique.

Stent graft in TIPS: technical and procedural aspects

Transjugular intrahepatic portosystemic shunt (TIPS) is a nonoperative therapeutic option for the management of portal hypertension, variceal bleeding, recurrent ascites, Budd–Chiari syndrome. In view of the many issues surrounding the use of TIPS, in 1994 the US National Digestive Diseases Advisory Board convened a scientific conference to review the current data available and to establish the indications and controindications for this procedure. However there are still unsolved problems especially short primary patency of the shunt due to intimal hyperplasia, which causes a reduction of the shunt lumen thus favoring a return of the portal hypertension with recurrent variceal bleeding. Several study were performed in the last years to evaluate the efficacy of covered stent in order to reduce shunt disfunction secondary to intimal hyperplasia. PTFE seems to be more efficient in the prevention of restenoses. In our experience more then 100 patients were treated with the Viatorr stent–graft. After a follow–up ranging from 1 to 50 months we reported a 1– year primary patency rate of 83.8%. However the use of the stentgraft is correlate with a high rate of hepatic hencefalopathy (46.6 %). In case of hepatic hencefalopathy refractory to the conventional medical therapy, TIPS reduction should be performed.

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.

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.