Abstract Objectives Aortic root replacement using a composite graft is the treatment of choice for a large variety of aortic root conditions with a diseased aortic valve. The objective of the current ...study was to evaluate the long-term results of this procedure. Methods Between 1978 and 2010, 1045 patients aged 58.7 ± 13.6 years underwent aortic root composite graft replacement using the following techniques: 95 Bentall operation; 926 the “button technique;” 24 the Cabrol technique. A mechanical composite valve graft was implanted in 69.6% of the patients. Six-hundred and thirty-five patients (62.3%) had annuloaortic ectasia and 162 (15.5%) had aortic dissection. Results Early mortality was 5.3% (55/1045). Independent risk factors for early mortality at logistic regression analysis were age ≥70 years ( P = .051; odds ratio OR, 2.97), New York Heart Association III-IV ( P = .052; OR, 1.88), reoperation ( P = .021; OR, 2.36), urgency/emergency ( P = .003; OR, 3.09), mitral valve replacement ( P = .001; OR, 6.01), or coronary artery bypass grafting (CABG) ( P < .001; OR, 4.39); while bicuspid aortic valve (BAV) ( P = .013; OR, 0.21), and time of operation 2001-2011 ( P = .025; OR, 0.60) were protective predictors for early mortality. Overall survival at 5, 10, and 20 years was 84.1% ± 1.3%, 65.5% ± 2.6%, and 40.7% ± 4.6%, respectively. Multivariate analysis revealed chronic renal insufficiency ( P = .001; hazard ratio HR, 3.48), chronic obstructive pulmonary disease ( P = .027; HR, 1.94), aortic dissection ( P = .001; HR, 2.63), Cabrol technique ( P = .009; HR, 15.34), and CABG ( P = .016; HR, 2.02) to be significant predictors of late death, and BAV ( P = .010; HR, 0.43) to be a significant protective predictor. Freedom from thromboembolism, bleeding complications, and endocarditis was 93.7% ± 2.6%, 90.3% ± 3.1%, and 98.4% ± 1% at 20 years, respectively. Freedom from aortic reoperation was 91.8% ± 2.1% at 20 years and was significantly lower in patients with aortic dissection. Conclusions Within the limitations of this retrospective study, we can conclude that aortic root replacement for aortic root aneurysms can be performed with low morbidity and mortality and with satisfactory long-term results. Few late serious complications were related to the need for long-term anticoagulation or a prosthetic valve. Reoperation on the proximal or in the distal aorta was most commonly performed in patients with aortic dissection.
Abstract Objectives The aim of this study was to appraise 2-year outcomes after percutaneous transluminal angioplasty of long femoropopliteal artery disease using paclitaxel-coated balloons (PCBs). ...Background Percutaneous transluminal angioplasty with PCBs for TransAtlantic Inter-Society Consensus types C and D femoropopliteal artery disease has provided favorable results ≤12 months but no prospective studies performed longer term follow-up assessment. Methods Consecutive patients with Rutherford class 2 to 4 disease due to femoropopliteal lesions >15 cm long were prospectively enrolled in a multicenter study. The primary study endpoint was primary patency (i.e., freedom from the combined endpoint of clinically driven target lesion revascularization and >50% restenosis in the treated lesion as appraised by a duplex ultrasound peak systolic velocity ratio of >2.4) at 24 months. Secondary endpoints included major adverse events (the composite of death, target limb amputation, thrombosis at the target lesion, or clinically driven nontarget lesion revascularization), changes in Rutherford class, and quality of life ≤24 months post-procedure. Results A total of 105 patients (age 68 ± 9 years; 81.9% men) successfully treated with PCBs were included (treated lesion length was 251 ± 71 mm; 49.5% total occlusions). The 24-month follow-up data were available in 98 patients; they showed a primary patency rate of 70.4%, with major adverse events occurred in 10 patients (10.2%, 5 non–procedure-related deaths) and persistently significant clinical benefits in Rutherford class (51% of asymptomatic patients at 24 months). Conclusions PCBs benefits on primary patency and target vessel revascularization satisfactorily extend over 24 months in patients undergoing percutaneous transluminal angioplasty for symptomatic femoropopliteal disease.
Abstract Objectives The aim of this study was to appraise 1-year outcomes after percutaneous treatment of long femoropopliteal artery disease using paclitaxel-coated balloons. Background Percutaneous ...transluminal angioplasty with paclitaxel-coated balloons for TransAtlantic Inter-Society Consensus types A and B femoropopliteal artery disease has provided favorable results. Methods Consecutive patients with Rutherford class 2 to 4 disease due to femoropopliteal lesions >15 cm long and with 4- to 7-mm reference vessel diameter were prospectively enrolled in a multicenter study. The primary study endpoint was primary patency at 12 months. Secondary endpoints included major adverse events (the composite of death, major target limb amputation, thrombosis at the target lesion site, or clinically driven non–target lesion target vessel revascularization), changes in Rutherford class, ankle-brachial index, and quality of life up to 24 months post-procedure. Results A total of 105 patients (mean age 68 ± 9 years, 81.9% men) treated with paclitaxel-coated balloons and provisional stenting were enrolled, and final procedural success was obtained in all. The mean treated lesion length was 251 ± 71 mm, including 63.4% moderate to severely calcified lesions and 49.5% total occlusions. The bailout stent rate was 10.9%. Follow-up after 12 months was obtained in 101 patients (96.2%), showing that primary patency was maintained in 84 (83.2%), and major adverse events had occurred in 7 (6.2%), with persistently significant clinical benefits in Rutherford class. Conclusions Paclitaxel-coated balloons are associated with favorable functional and clinical outcomes at 1 year in patients with long femoropopliteal artery disease requiring percutaneous revascularization. (Drug Eluting Balloon DEB and Long Lesions of Superficial Femoral Artery SFA Ischemic Vascular Disease DEB-SFA-LONG; NCT01658540 )
IL-2 plays a pivotal role in regulating the adaptive immune system by controlling the survival and proliferation of regulatory T (Treg) cells, which are required for the maintenance of immune ...tolerance. Moreover, IL-2 is implicated in the differentiation and homeostasis of effector T-cell subsets, including TH 1, TH 2, TH 17, and memory CD8+ T cells. The IL-2 receptor is composed of 3 distinct subunits, namely the α (CD25), β (CD122), and γ (γc) chains. Of crucial importance for the delivery of IL-2 signals to Treg cells is the expression of CD25, which, along with CD122 and γc, confers high affinity binding to IL-2. Notably, recent findings suggest a novel role for CD25, whereby CD25 molecules on Treg cells and possibly other cells are capable of influencing T-cell homeostasis by means of IL-2 deprivation. This review explores these findings and integrates them into our current understanding of T-cell homeostasis.
Objectives This study aimed to appraise 2-year outcomes after percutaneous treatment of femoropopliteal artery disease with paclitaxel-eluting balloons. Background Percutaneous transluminal ...angioplasty with paclitaxel-eluting balloons for femoropopliteal artery disease has provided favorable 1-year results. Methods Consecutive patients with Rutherford class 2 to 4 disease due to femoropopliteal lesions ≤15 mm long and with 3- to 7-mm reference vessel diameter were prospectively enrolled in a multicenter registry. Endpoints of interest included primary patency, major adverse events (the composite of death, amputation, or target lesion revascularization), changes in Rutherford class, ankle-brachial index, absolute claudication distance, and quality of life after ≥24 months. Results A total of 105 patients (114 lesions) treated with paclitaxel-eluting balloons and provisional stenting were enrolled, and final procedural success was obtained in all. Follow-up after 27 ± 3 months was obtained in 98 (93.3%) patients, showing that primary patency was maintained in 71 (72.4%), and major adverse events had occurred in 17 (17.5%), with persistently significant benefits in Rutherford class, ankle-brachial index, absolute claudication distance, and quality of life (all p < 0.001). Secondary patency rate was achieved in 89 cases (84.7%). Conclusions PEBs are associated with favorable functional and clinical outcomes at 2 years in patients with femoropopliteal artery disease requiring percutaneous revascularization.
Background This study assessed the early and long-term results of arch operations performed after a prior aortic operation. Methods From 1994 to 2014, 154 consecutive patients (mean age, 59.7 years) ...underwent an aortic arch repair, after a previous aortic operation, at our institution. Antegrade selective cerebral perfusion was used in all cases. Chronic postdissection aortic aneurysm (87 56.5%) and degenerative aneurysm (43 27.9%) represented the most common indications for surgical intervention. A complete arch replacement was performed in 119 patients (77.3%), an associated root repair in 70 (45.5%), and the frozen elephant trunk technique was used in 55 (35.7%). Results Hospital mortality was 11.7% (n = 18). Postoperative permanent neurologic dysfunction occurred in 10 patients (6.4%). On multivariate analysis, cardiopulmonary bypass time (odds ratio, 1.02 per minute; p = 0.005) emerged as the only independent predictor of hospital death. Follow-up was 100% complete. The estimated survival at 1, 5, and 10 years was 79.6%, 69.9%, and 46.8%, respectively. Freedom from reoperation was 75.6% at 5 years and 54.6% at 10 years. Cox regression identified chronic postdissection aortic aneurysm (odds ratio, 4.2; p = 0.006) to be the only independent predictor of aortic reintervention. Late survival was comparable between degenerative aneurysm patients and the Italian population matched for age and sex (standardized mortality ratio, 1.9; p = 0.1). Longevity was reduced in patients operated on for chronic postdissection aortic aneurysm (standardized mortality ratio, 6.3; p < 0.001). Conclusions Arch operations after a previous open aortic repair can be performed with acceptable mortality and good long-term outcomes. Complete aortic resection did not increase hospital deaths and was associated with a low need for aortic reinterventions at follow-up.
Abstract Background The development of acute kidney injury (AKI) in cardiac surgery is associated with increased morbidity and mortality. The aim of the study was to assess the incidence and risk ...factors for AKI after thoracic aorta surgery, using antegrade selective cerebral perfusion (ASCP) and moderate hypothermia. Methods We reviewed 641 patients undergoing thoracic aortic surgery, using ASCP and moderate hypothermia, from November 1996 to December 2012. Patient preoperative, intraoperative, and postoperative variables were evaluated for association with AKI with logistic regression analysis. Models including all variables and models, after the sequential removal of postoperative, and both postoperative and intraoperative variables, were assessed using receiver operating characteristic analysis. Results The mean age of the patients was 62.9 years, and 194 patients (30%) were women. The overall incidence of AKI was 19.0%. In-hospital mortality was significantly higher in the AKI group (33.6% vs 6.7%; P < .001). Logistic regression analysis identified 8 predictors of AKI: 4 of them were preoperative (priority, diabetes, preoperative glomerular filtration rate, and weight); 2 intraoperative (mitral valve and aortic valve replacement); and 2 postoperative (overall neurologic complication and reoperation for bleeding). Model-discrimination performance improved from an area under the curve (AUC) of 0.737, for the model including only preoperative variables, to an AUC of 0.798 for the model including all variables ( P = .012). Conclusions The incidence of AKI after thoracic aorta surgery is fairly common, and its occurrence strongly affects outcomes. Preoperative renal status and preoperative conditions are the main influences on AKI development. Predictive models can be improved by adding intraoperative and postoperative variables.
Summary Background Natalizumab is used to prevent relapses and progression of disability in patients with multiple sclerosis but has been associated with progressive multifocal leukoencephalopathy ...(PML). We aimed to better understand the associations between JC virus, which causes PML, and natalizumab treatment. Methods We prospectively assessed patients with multiple sclerosis who started treatment with natalizumab. Blood and urine samples were tested for the presence of JC virus DNA with quantitative real-time PCR before treatment and at regular intervals after treatment onset for up to 18 months. At the same timepoints, by use of proliferation and enzyme-linked immunospot assays, the cellular immune responses against JC virus, Epstein-Barr virus, cytomegalovirus, myelin oligodendrocyte glycoprotein, and myelin oligodendrocyte basic protein (MOBP) were assessed. Humoral immune response specific to JC virus was assessed with an enzyme immunoassay. The same experiments were done on blood samples from patients with multiple sclerosis before and 10 months after the start of interferon beta treatment. Findings We assessed 24 patients with multiple sclerosis who received natalizumab and 16 who received interferon beta. In patients treated with natalizumab, JC virus DNA was not detected in the blood at any timepoint. However, JC virus DNA was present in the urine of six patients and in most of these patients the concentrations of JC virus DNA were stable over time. Compared with pretreatment values, the cellular immune response was increased to cytomegalovirus at 6 months, to JC virus at 1, 9, and 12 months, and to Epstein-Barr virus and MOBP at 12 months. Humoral responses remained stable. There were no increases in cellular immune responses specific to the viruses or myelin proteins in the 16 patients treated with interferon beta. Interpretation Natalizumab increases cellular immune responses specific to viruses and myelin proteins in the peripheral blood after 1 year, without evidence of viral reactivation. Funding Swiss National Foundation, Swiss Society for Multiple Sclerosis, and Biogen Dompé.
Abstract Background In heart failure (HF), women show better survival despite a comparatively low peak oxygen consumption ( V ˙ o2 ): this raises doubt about the accuracy of risk assessment by ...cardiopulmonary exercise testing (CPET) in women. Accordingly, we aimed to check (1) whether the predictive role of well-known CPET risk indexes, ie, peak V ˙ o2 and ventilatory response ( V ˙ e / V ˙ co2 slope), is sex independent and (2) if sex-related characteristics that impact outcome in HF should be considered as associations that may confound the effect of sex on survival. Methods The study population consisted of 2985 patients with HF, 498 (17%) of whom were women, from the multicentre Metabolic Exercise Test Data Combined with Cardiac and Kidney Indexes (MECKI): the end point was cardiovascular death within a 3-year period. Results During the follow-up, 305 (12%) men and 39 (8%) women ( P = 0.005) died, and female sex was linked to better survival on univariate analysis ( P = 0.008) and independent of peak V ˙ o2 and V ˙ e / V ˙ co2 slope on multivariate analysis. According to propensity score matching for female sex to exclude a sex selection bias and sample discrepancy, 498 men were selected: the standardized percentage bias ranged from 20.8 ( P < 0.0001) to 3.3 ( P = 0.667). After clinical profile harmonizing, female sex was predictive of HF at univariate analysis. Conclusions The low peak V ˙ o2 and female association with better outcome in HF might be counterfeit: the female prognostic advantage is lost when sex-specific differences are correctly taken into account with propensity score matching, suggesting that for an effective and efficient HF model, adjustment must be made for sex-related characteristics.
Objectives This study evaluated the use of a paclitaxel-eluting balloon (PEB) for treatment of femoropopliteal arterial disease. Background Conventional balloon angioplasty and stenting in this ...setting is associated with high restenosis rates within 12 months. Recent data suggest that PEB use may reduce restenosis. Twelve-month outcomes following PEB use with provisional stenting are described. Methods This prospective registry enrolled patients (Rutherford class 2 to 4) with reference vessel diameter of 3 to 7 mm and lesion/occlusion length ≤15 cm. Endpoints included primary patency rate, target lesion revascularization, and changes in Rutherford class and ankle-brachial index. Walking capacity, absolute claudication distance, and quality of life were also assessed. Results The registry enrolled 105 patients. Baseline ankle-brachial index was 0.56 ± 0.15. Baseline Rutherford classification was class 2 or 3 for most patients (91.5%). Most lesions were located in the superficial femoral artery (77.1%). Mean lesion length was 76.3 ± 38.3 mm; 29.8% of lesions were total occlusions. The device was successfully used in all patients and only 12.3% of lesions required stenting. At 12-month follow-up, 92 of 105 patients (87.6%) were evaluable; the primary patency rate was 83.7%; the target lesion revascularization rate was 7.6%; 85.6% of patients were Rutherford class 0 or 1; and mean ankle-brachial index was 0.86 ± 0.15. Quality of life and absolute claudication distance showed significant improvement from baseline to 12-month follow-up. Conclusions PEB treatment of femoropopliteal arterial disease resulted in consistent clinical improvement across multiple endpoints with a low rate of stenting and target lesion revascularization.