Costantino Del Giudice

Simultaneous Hybrid Revascularization by Carotid Stenting and Coronary Artery Bypass Grafting – The SHARP Study

OBJECTIVES In an attempt to reduce post-operative events we investigated a new therapeutic strategy consisting of a simultaneous hybrid revascularization by carotid artery stenting (CAS), immediately followed by an on-pump coronary artery bypass graft (CABG). BACKGROUND Preventing stroke and cardiovascular events after coronary artery revascularization in patients with elevated surgical risk is a complex and multifaceted problem. METHODS One hundred-one consecutive patients with severe carotid and coronary artery disease and a standard EuroSCORE >or=5 were included in this multicenter study. Immediately after CAS, patients underwent CABG. The primary end point was the incidence of stroke, acute myocardial infarction (AMI), or death at 30 days. Secondary outcomes were transient ischemic attacks; major local complications; bleeding and systemic complications within 30 days after treatment; and any stroke, AMI, or death occurring from the 31st day to the end of the 12-month follow-up. All clinical outcomes were assessed by an independent monitoring board. RESULTS The rate of procedural success was 98%. The 30-day cumulative incidence of disabling stroke, AMI, or death was 4%: 2 patients died (2%) in the post-operative period, and 2 patients (2%) had a stroke immediately after CAS and before CABG. Three patients died from the 31st day to the 12th month after the procedure. CONCLUSIONS Our findings indicate that in high-risk patients with coronary artery disease suitable for CABG and carotid artery disease, the hybrid revascularization by CAS immediately followed by CABG is a promising and feasible therapeutic strategy.

Kidney Transplant: Usefulness of Real-Time Elastography (RTE) in the Diagnosis of Graft Interstitial Fibrosis

The aim of this study is to evaluate the usefulness of real-time elastography (RTE) in the diagnosis of graft interstitial fibrosis. We prospectively enrolled 50 patients clinically suspected of graft fibrosis. RTE was performed with a broadband linear transducer using a dedicated ultrasound machine. Tissue mean elasticity (TME) was calculated by two blinded operators. All patients underwent biopsy after RTE. To determine cortical fibrosis Banff score was used. The receiver operating characteristic curves analysis was performed to evaluate the accuracy of TME to discriminate between patients with mild fibrosis (F1) versus patients with moderate to severe fibrosis (F2-F3). Inverse correlation between TME values and the degree of fibrosis has been shown (p < 0.05). Patients with F1 had mean TME values significantly higher compared with TME in patients with F2 (p = 0.005) and F3 (p = 0.004). The diagnostic accuracy of TME measurement for F2-F3 evaluated by area under the curve-receiver operating characteristic analysis was 0.95. RTE was able to evaluate kidney fibrosis in a non-invasive way and could be used as complementary imaging during follow-up of renal transplant patients.

Intra-arterial Thrombectomy versus Standard Intravenous Thrombolysis in Patients with Anterior Circulation Stroke Caused by Intracranial Arterial Occlusions: A Single-center Experience

BACKGROUND Severely impaired patients with persisting intracranial occlusion despite standard treatment with intravenous (IV) administration of recombinant tissue plasminogen activator (rtPA) or presenting beyond the therapeutic window for IV rtPA may be candidates for interventional neurothrombectomy (NT). The safety and efficacy of NT by the Penumbra System (PS) were compared with standard IV rtPA treatment in patients with severe acute ischemic stroke (AIS) caused by large intracranial vessel occlusion in the anterior circulation. METHODS Consecutive AIS patients underwent a predefined treatment algorithm based on arrival time, stroke severity as measured by the National Institutes of Health Stroke Scale (NIHSS) score, and site of arterial occlusion on computed tomographic angiography (CTA). NT was performed either after a standard dose of IV rtPA (bridging therapy [BT]) or as single treatment (stand-alone NT [SAT]). Rates of recanalization, symptomatic intracranial bleeding (SIB), mortality, and functional outcome in NT patients were compared with a historical cohort of IV rtPA treated patients (i.e., controls). Three-month favourable outcome was defined as a modified Rankin Scale (mRS) score ≤2. RESULTS Forty-six AIS patients were treated with NT and 51 with IV rtPA. The 2 groups did not differ with regard to demographics, onset NIHSS score (18.5±4 v 17±5; P=.06), or site of intracranial occlusion. Onset-to-treatment time in the NT and IV rtPA groups was 230 minutes (±78) and 176.5 (±44) minutes, respectively (P=.001). NT patients had significantly higher percentages of major improvement (≥8 points NIHSS score change at 24 hours; 26% v 10%; P=.03) and partial/complete recanalization (93.5% v 45%; P<.0001) compared to controls. Treatment by either SAT or BT similarly improved the chance of early recanalization and early clinical improvement. No significant differences were observed in the rate of SIB (11% v 6%), 3-month mortality (24% v 25%), or favorable outcome (40% v 35%) between NT and IV rtPA patients. CONCLUSIONS Despite significantly delayed time of intervention, NT patients had higher rates of recanalization and early major improvement, with no differences in symptomatic intracranial hemorrhages. Early NIHSS score improvement did not translate into better 3-month mortality or outcome. NT seems a safe and effective adjuvant treatment strategy for selected patients with severe AIS secondary to large intracranial vessel occlusion in the anterior circulation.

Long-term results of drug-eluting balloon angioplasty for treatment of refractory recurrent carotid in-stent restenosis.

Purpose To evaluate the potential role, safety, and efficacy of paclitaxel-eluting balloon angioplasty for treatment of recurrent carotid in-stent restenosis (ISR). Methods Among 856 consecutive patients who underwent carotid artery stenting from May 2002 to January 2008, 41 patients had a significant ISR (>80% stenosis). Of these, 9 patients (7 women; mean age 78.1±5.6 years) had recurrent ISR despite multiple endovascular treatments (3.4±0.9 interventions) within a short period of time (2–5 months). These patients were treated with drug-eluting balloon (DEB) angioplasty for neointimal hyperplasia. Imaging (ultrasound or computed tomographic angiography) was performed at 1, 3, and 6 months and yearly thereafter. Results Technical success was obtained in 100% of cases, with angiographic stenosis decreasing from 87%±4% to 6%±4% post treatment. Peak systolic velocity decreased significantly from 4.7±1.5 m/s to 0.6±0.3 m/s after the procedure. Over a mean follow-up of 36.6±2.7 months, ultrasound imaging indicated recurrent ISR in only 3 patients at 18, 25, and 32 months after DEB angioplasty, respectively. The target vessel revascularization rate was 33.3% at 36 months. No neurological or myocardial events were recorded during follow-up. One patient died at 3 months. Conclusion DEB may have a potential role improving outcomes of those patients treated for early recurrent carotid ISR.

Six-Month Results From the Initial Randomized Study of the Ranger Paclitaxel-Coated Balloon in the Femoropopliteal Segment:

Purpose: To evaluate the performance of the Ranger paclitaxel-coated balloon vs uncoated balloon angioplasty for femoropopliteal lesions. Methods: Between January 2014 and October 2015, the prospective, randomized RANGER SFA study ( ClinicalTrials.gov identifier NCT02013193) enrolled 105 patients with symptomatic lower limb ischemia (Rutherford category 2–4) and stenotic lesions in the nonstented femoropopliteal segment at 10 European centers. Seventy-one patients (mean age 68±8 years; 53 men) were enrolled in the Ranger drug-coated balloon (DCB) arm and 34 patients (mean age 67±9 years; 23 men) were assigned to the control group. Six-month analysis included angiographic late lumen loss and safety and clinical outcomes assessments. Results: Baseline characteristics of the DCB and control groups were similar, as were lesion lengths (68±46 vs 60±48 mm; p=0.731), severity of calcification (p=0.236), and the prevalence of occlusions (34% vs 34%; p>0.999). At 6 months, late lumen loss was significantly less for the DCB group vs controls (–0.16±0.99 vs 0.76±1.4; p=0.002). The DCB group had significantly greater freedom from binary restenosis (92% vs 64%; p=0.005) and primary patency rates (87% vs 60%; p=0.014). Target lesion revascularization rates were 5.6% in the DCB group and 12% in the control group (p=0.475). No target limb amputations or device-related deaths occurred in either group. Conclusion: Six-month results suggest that Ranger DCB treatment effectively inhibited restenosis in symptomatic femoropopliteal disease, resulting in improved vessel patency and a low revascularization rate in the short term compared with uncoated balloon angioplasty.

Treatment of type II endoleak after endovascular aneurysm repair: the role of selective vs. nonselective transcaval embolization.

Purpose To assess the technical and midterm results in the treatment of type II endoleaks comparing nonselective (nTCE) vs. selective (sTCE) transcaval embolization. Methods During a 4-year period, 26 patients (18 men; median age 73 years, range 68–78) underwent direct transcaval aneurysm puncture followed by embolization of the sac (nTCE, n=9) or of the feeding vessels (sTCE, n=17). Intrasac pressure was recorded immediately after aneurysm sac puncture and at the end of the procedure. Technical success was defined as successful deployment of embolization material in the sac or in the feeding vessel. Clinical success was defined as absence of endoleak with stabilization of the sac on follow-up CTA. Results Technical success was 100% in the 9 patients treated with nTCE. Mean intrasac pressures before and after nTCE were 58.6±18.4 (range 51–105) and 6.5±1.2 mmHg (range 4–9), respectively. Over a mean 25.9±11.0 months of follow-up, 4 patients developed recurrent endoleak at a mean 9.7±3.9 months. Three patients were subsequently treated with sTCE, while the last patient underwent emergency surgery for aneurysm rupture due to an enlarging sac 5 months after nTCE. The 20 patients in the sTCE group had a successful procedure with no recurrence in a follow-up of 24.1±7.2 months. Mean intrasac pressure was reduced after sTCE from 63.6±15.2 mmHg (range 43–120) to 7.8±2.3 mmHg (range 5–12). Conclusion The selective TCE approach appears to be a feasible and effective primary therapeutic option for treating type II endoleak.

Stent Puncture for Recanalization of Occluded Superficial Femoral Artery Stents

Purpose To describe a technique to recanalize occluded superficial femoral artery (SFA) stents without inflow or outflow in patients with proximal SFA obstruction. Technique After a failed attempt to engage an occluded stent through an antegrade femoral approach, a distal retrograde puncture of the proximal part of the stent was performed. After subintimal rendezvous with a catheter advanced from the antegrade access, in-stent angioplasty can be performed to recanalize the stent and SFA. Conclusion Direct retrograde puncture of an occluded stent may be considered an approach to recanalization in patients with stent occlusion and no inflow or outflow.

A case of coronary artery fistula visualized by 64-slice multidetector CT.

Background A 27-year-old woman was admitted to hospital with a 1-year history of mild dyspnea.Investigations Physical examination, chest radiography, electrocardiography, transthoracic echocardiography, 64-slice multidetector CT and coronary angiography.Diagnosis Fistula originating from the left anterior coronary artery and draining into the right ventricle, in conjunction with an aneurysm of the left anterior descending artery.Management Surgical closure of the fistula using normothermic cardiopulmonary bypass.

Prediction of Cardiovascular Events by Inflammatory Markers in Patients Undergoing Carotid Stenting

OBJECTIVE To assess whether inflammatory markers predict atherosclerotic disease activity after carotid treatment in patients with severe carotid stenosis and nonsignificant coronary artery disease undergoing carotid stenting. PATIENTS AND METHODS From March 1, 2004, to September 30, 2005, a total of 55 consecutive patients (mean ± SD age, 69±8.3 years; 26 men) with severe carotid stenosis and nonsignificant coronary artery disease were treated with carotid stent implantation. Patients were followed up for a period of 5 years for the occurrence of cardiovascular events. RESULTS A significant correlation between quantitative analysis of debris entrapped in the filters and inflammatory markers was found. Moreover, the number of particles per filter, the total particles area, and the mean particle axis per filter were significantly higher in patients with clinical events at the follow-up compared with patients without events (87 vs 32, P=.006; 50,118.7 vs 17,782, P=.002; 33.9 vs 30.2, P=.03). At 5-year follow-up we recorded cardiovascular or neurologic events in 11 of the 55 patients (20%). Higher preprocedural levels of high-sensitivity C-reactive protein, interleukin 6 soluble receptor, and interleukin 6 were significantly associated with clinical events at follow-up (P<.001, P=.05, and P=.02, respectively). In particular high-sensitivity C-reactive protein measured at 24 and 48 hours after carotid stenting showed a significant correlation with clinical events (P=.001). Also preprocedural intracellular adhesion molecule 1 and circulating vascular cell adhesion molecule 1 blood concentrations were significantly correlated with a worse prognosis at follow-up (P=.04 and P=.03, respectively). CONCLUSION In patients with severe carotid stenosis and nonsignificant coronary artery disease, inflammation is associated with atherosclerotic disease activity and a worse prognosis. Interleukin 6, interleukin 6 soluble receptor, intracellular adhesion molecule 1, vascular cell adhesion molecule 1, and high-sensitivity C-reactive protein levels at baseline and 24 and 48 hours after carotid stenting are predictive of neurologic and cardiovascular events at follow-up.

Downstaging disease in patients with hepatocellular carcinoma outside up-to-seven criteria: Strategies using degradable starch microspheres transcatheter arterial chemo-embolization.

AIM To evaluate the downstaging rates in hepatitis C virus-patients with hepatocellular carcinoma (HCC), treated with degradable starch microspheres transcatheter arterial chemoembolization (DSM-TACE), to reach new-Milan-criteria (nMC) for transplantation. METHODS This study was approved by the Ethics Committee of our institution. From September 2013 to March 2014 eight patients (5 men and 3 women) with liver cirrhosis and multinodular HCC, that did not meet nMC at baseline, were enrolled in this study. Patients who received any other type of treatment such as termal ablation or percutaneous ethanol injection were excluded. DSM-TACE was performed in all patients using EmboCept(®) S and doxorubicin. Baseline and follow-up computed tomography or magnetic resonance imaging was assessed measuring the longest enhancing axial dimension of each tumor according to the modified Response Evaluation Criteria In Solid Tumors measurements, and medical records were reviewed. RESULTS DSM-TACE was successfully performed in all patients without major complication. We treated 35 lesions (mean 4.3 per patient). Six of eight patients (75%) had their HCC downstaged to meet nMC. Every patient whose disease was downstaged eventually underwent transplantation. The six patients who received transplant were still living at the time of this writing, without recurrence of HCC. Baseline age (P = 0.25), Model for End-stage Liver Disease score (P = 0. 77), and α-fetoprotein level (P = 1.00) were similar between patients with and without downstaged HCC. CONCLUSION DSM-TACE represents a safely and effective treatment option with similar safety and efficacy of conventional chemoembolization and could be successfully performed also for downstaging disease in patients without nMC, allowing them to reach liver transplantation.