Local release of metalloproteinases and their inhibitors after a successful revascularisation procedure.

An altered balance between metalloproteinases (MMPs) and their inhibitor tissue inhibitor of metalloproteinases (TIMPs) may influence the healing process of a minor amputation following a successful vein graft. To speed up this process, negative pressure wound therapy (NPWT) and advanced moist wound dressing have been proposed. We determined the systemic and local release of MMP-1, -2, -3, -9, TIMP-1, and TIMP-2 by enzyme linked immunosorbent assay (ELISA) technique and their influences in the healing process in 26 patients who underwent minor amputation after a successful revascularisation procedure. Twelve patients (group 1) were medicated with NPWT and 14 (group 2) with advanced moist wound dressing. Plasma samples were collected on the morning of surgery and thereafter at 1, 3, and 5 months; exudates were collected 3 days after surgery when amputation was performed and thereafter at 1, 3, and 5 months. Fifteen age-matched healthy male volunteers served as controls. All wounds healed in 5 ± 0.5 months. Follow-up plasma and local release of MMP-1, -2, -3, and -9 were overall significantly lower when compared with the preoperative levels, while those of TIMP-1 and -2 were significantly higher with no differences among the groups. Despite no differences in the healing process being observed among the two types of medications, at 1 month the local release of MMP-2 and -9 was significantly lower (P = .013 and .047, respectively) and that of TIMP-1 was significantly higher (P = .042) in group 1 as compared to group 2. A correct and aggressive local approach to the wound is able to promote the healing of the lesion stimulating the extracellular matrix turnover with local MMP/TIMP adequate balance and favouring the creation of granulation tissue. However, a successful restoration of an adequate blood flow remains the key point of a durable and rapid wound healing.

External Iliac Artery to Tibial Arteries Vein Graft for Inaccessible Femoral Artery.

BACKGROUND: An endovascular-first approach to limb salvage and relief from lifestyle-limiting claudication is widely accepted. Stenosis or short occlusion of common, superficial femoral, and popliteal arteries can be corrected with percutaneous transluminal angioplasty (PTA) with stent positioning. Patency rates of these procedures are limited. We report our experience with external iliac artery to the infrapopliteal vessels vein grafts when the endovascular treatment fails. METHODS: Between January 2013 and January 2019, 16 patients (16 limbs) were operated on for limb-threatening ischemia after the occlusion of PTA with stent positioning of the common, superficial femoral, and popliteal arteries. Three patients were treated at our hospital by interventional radiologists; the remaining were operated on elsewhere. An external iliac artery to the infrapopliteal vessels vein bypass graft was anatomically interposed to restore blood flow. End points of the study were death-related events, vein graft failure, and major (above- or below-knee amputation) or minor (foot or toe amputation) limb loss. RESULTS: There were 12 men and 4 women. Mean age of patients was 68 years. Indication for the initial PTA with stent positioning of the common and superficial femoral artery was according to the Rutherford classification Grade I: Category 1, 11 patients (69%) and Category 2, 5 (31%) patients (Stage IIa and IIb according to Fontaine classification, respectively). Great saphenous vein was used in 14 (87%) cases and in 2 (13%) cases a composite graft with a segment of cephalic vein was required. The distal anastomoses were performed on the posterior tibial artery in 6 (37%) cases, anterior tibial artery in 4 (26%), and peroneal artery in 6 (37%). Four-year survival and primary patency rates were 71% (standard error [SE] = 0.15) and 73% (SE = 0.14), respectively. One graft occlusion required an above-knee amputation. Four-year limb salvage rate was 86% (SE = 0.13). DISCUSSION: We recommend the external iliac artery as source of inflow in patients in whom the vein bypass cannot originate from the common femoral or from a more distal inflow source because of previous PTA with stent positioning or it is deemed hazardous.

Different inflammatory cytokines release after open and endovascular reconstructions influences wound healing.

Prodromal signs of a non-healing wound after revascularisation, which might be strictly linked with impending failure of vascular reconstructions, are associated with an inflammatory response mediated by several circulating adhesion molecules, extracellular endopeptidases, and cytokines. The aim of our study was to investigate the role of selected plasma biomarkers in the prediction of both wound healing and failure of infrapopliteal vein graft or percutaneous trans-luminal angioplasty (PTA) with selective stent positioning of the superficial femoral artery (SFA) in a population affected with critical limb ischaemia. A total of 68 patients who underwent either surgical or endovascular revascularisation of the inferior limb with autologous saphenous vein infrapopliteal bypass or PTA and selective stenting of the SFA were enrolled in our study. Patients were divided into two groups according to treatment: 41 patients were included in Group 1 (open surgery) and 27 in Group 2 (endovascular procedure). Plasma and blood samples were collected on the morning of surgery and every 6 months thereafter for up to 2 years of follow-up or until an occlusion occurred of either the vein bypass graft or the vessel treated endovascularly. Fifteen age-matched healthy male volunteers were considered a reference for biological parameters. Vascular cell adhesion molecule 1 [VCAM-1]/CD106, inter-cellular adhesion molecule-1 [ICAM-1]/CD54), interleukin-1 (IL-1), interleukin-6 (IL-6), tumour necrosis factor alpha (TNF-α), and metalloproteinases (MMP)-2 and -9 plasma levels were measured with enzyme-linked immunosorbent assay (ELISA) kits. The mean observed time to heal of 54 wounds was 13 ± 4 months, with no statistically significant differences among the groups. The healing failure of the remaining wounds was strictly related to an unsuccessful open (n = 12) or endovascular (n = 8) treatment. The 2-year primary patency rate was 65% (SE = .09) in Group 1 and 52% (SE = .1) in Group 2. When compared with mean concentration values of Group 1, VCAM-1 and ICAM-1 were always significantly higher during follow-up in patients of Group 2 (P < .05). Furthermore, in the same group, IL-6 and tumour necrosis factor alpha (TNF-α) were found to be significantly higher at 6- and 12-month (P < .05) when compared with surgically treated patients. Cox regression analysis showed that elevated plasma levels of VCAM-1, ICAM-1, IL-6, and TNF-α during follow up were strongly related to impaired wound healing and/or revascularisation failure (P < .05). Elevated plasma levels of inflammatory markers VCAM-1, ICAM-1, IL-6, and TNF-α may be related to the failure of wound healing and revascularisation procedures. Interestingly, we have observed that endovascular treatments cause a higher level of these inflammation biomarkers when compared with a vein graft, although wound-healing and patency and limb salvage rates are not influenced.

Symptoms in patients with skin changes due to chronic venous insufficiency often lead to emergency care service: an Italian observational study.

Chronic venous insufficiency (CVI) is the most advanced form of chronic venous disease (CVD), and is often associated with skin changes such as hyperpigmentation, eczema, lipodermatosclerosis and venous skin ulceration that cause discomfort, pain, sleep disturbances, absenteeism in the workplace, disability and deteriorated quality of life (QoL). The purpose of this study is to evaluate the prevalence of CVI and skin changes in patients who turn to Continuous Assistance Services due to the presence of disturbing symptoms of their condition. Data were evaluated by consulting the medical records, during a 16-month period, available with three Continuous Assistance Services of the Italian territory. The overall population of the referring centres consisted of 1186 patients [739 females (62·31%) and 447 males (37·69%)]. Seventy-nine patients (6·66%) consulted the emergency unit for venous symptoms related to CVD. Patients with more severe disease (CVI, categories C4-C6) represented the majority accounting for 60·75%, while patients with moderate disease (C3) accounted for 35·44% and patients with mild disease (C1-C2 stages) accounted for 3·79%. The main finding of this study is that despite CVI not being a disease that commonly requires medical emergency/urgency intervention, patients with CVI, especially in advanced stage with skin changes, may turn to Continuous Assistance Service for treating bothersome symptoms related to their condition.

Contralateral Snare Cannulation vs. Retrograde Gate Cannulation during Endovascular Aortic Repair in Difficult Iliac Artery Anatomy: A Single Center Experience.

OBJECTIVE: Endovascular aneurysm repair is well established as the gold standard in treating abdominal aortic aneurysms. Generally, endovascular repair is performed using a bi or trimodular stent graft, requiring placement of a contralateral iliac limb. Deployment of the contralateral iliac limb requires retrograde gate cannulation of the endograft main body contralateral limb. This step represents the crucial point of a standard endovascular repair procedure and can become challenging, especially in the case of high iliac tortuosity. This study compares the procedural times between the retrograde gate cannulation and the contralateral snare cannulation to demonstrate the possibility of directly performing the contralateral snare cannulation in the case of a complex iliac anatomy assessed by the iliac tortuosity index. METHODS: One hundred and forty-eight patients with infrarenal abdominal aortic aneurysms who underwent endovascular aneurysm repair from 2017 to 2022 were analyzed retrospectively. Cannulation times between retrograde gate cannulation and contralateral snare cannulation were compared for each degree of iliac tortuosity. The degree of iliac tortuosity was assessed through the iliac tortuosity index. Cannulation times were detected from inserting the wire into the introducer to passing through the radio-opaque gate markers. RESULTS: The cannulation times were 2.94 min for the retrograde gate cannulation group and 3.15 min for the contralateral snare cannulation group, respectively, with no statistically significant differences (p = 0.33). Overall cannulation times were 2.98 min. For the iliac tortuosity index grade 0, the cannulation times were 2.71 min for the retrograde gate cannulation group and 3.85 min for the contralateral snare cannulation group, respectively, with a significant difference in favor of the retrograde gate cannulation group (p < 0.0001). For the iliac tortuosity index grade 1, the cannulation times were 2.74 min for the retrograde gate cannulation group and 2.8 min for the contralateral snare cannulation group, respectively, with no statistically significant differences (p = 0.63). Regarding the iliac tortuosity index grades 2 and 3, the cannulation times were 3.01 and 4.93 min for the retrograde gate cannulation group and 2.71 and 3.28 min for the contralateral snare cannulation group, respectively. The first group's times were significantly higher than the second group's (p = 0.01 and p = 0.0001). CONCLUSIONS: In patients with infrarenal abdominal aortic aneurysms undergoing endovascular aortic repair, the gate cannulation times were significantly shorter for the contralateral snare cannulation method than the retrograde gate cannulation method in the iliac tortuosity index grades 2 and 3. Therefore, performing the contralateral snare cannulation method would be appropriate.

Sex-Related Differences and Factors Associated with Peri-Procedural and 1 Year Mortality in Chronic Limb-Threatening Ischemia Patients from the CLIMATE Italian Registry.

BACKGROUND: Identifying sex-related differences/variables associated with 30 day/1 year mortality in patients with chronic limb-threatening ischemia (CLTI). METHODS: Multicenter/retrospective/observational study. A database was sent to all the Italian vascular surgeries to collect all the patients operated on for CLTI in 2019. Acute lower-limb ischemia and neuropathic-diabetic foot are not included. FOLLOW-UP: One year. Data on demographics/comorbidities, treatments/outcomes, and 30 day/1 year mortality were investigated. RESULTS: Information on 2399 cases (69.8% men) from 36/143 (25.2%) centers. Median (IQR) age: 73 (66-80) and 79 (71-85) years for men/women, respectively (p < 0.0001). Women were more likely to be over 75 (63.2% vs. 40.1%, p = 0.0001). More men smokers (73.7% vs. 42.2%, p < 0.0001), are on hemodialysis (10.1% vs. 6.7%, p = 0.006), affected by diabetes (61.9% vs. 52.8%, p < 0.0001), dyslipidemia (69.3% vs. 61.3%, p < 0.0001), hypertension (91.8% vs. 88.5%, p = 0.011), coronaropathy (43.9% vs. 29.4%, p < 0.0001), bronchopneumopathy (37.1% vs. 25.6%, p < 0.0001), underwent more open/hybrid surgeries (37.9% vs. 28.8%, p < 0.0001), and minor amputations (22% vs. 13.7%, p < 0.0001). More women underwent endovascular revascularizations (61.6% vs. 55.2%, p = 0.004), major amputations (9.6% vs. 6.9%, p = 0.024), and obtained limb-salvage if with limited gangrene (50.8% vs. 44.9%, p = 0.017). Age > 75 (HR = 3.63, p = 0.003) is associated with 30 day mortality. Age > 75 (HR = 2.14, p < 0.0001), nephropathy (HR = 1.54, p < 0.0001), coronaropathy (HR = 1.26, p = 0.036), and infection/necrosis of the foot (dry, HR = 1.42, p = 0.040; wet, HR = 2.04, p < 0.0001) are associated with 1 year mortality. No sex-linked difference in mortality statistics. CONCLUSION: Women exhibit fewer comorbidities but are struck by CLTI when over 75, a factor associated with short- and mid-term mortality, explaining why mortality does not statistically differ between the sexes.

One-year outcomes of cohort 1 in the Edwards SAPIEN Aortic Bioprosthesis European Outcome (SOURCE) registry: the European registry of transcatheter aortic valve implantation using the Edwards SAPIEN valve.

BACKGROUND: Transcatheter aortic valve implantation was developed to provide a therapeutic option for patients considered to be ineligible for, and to mitigate mortality and morbidity associated with, high-risk surgical aortic valve replacement. METHODS AND RESULTS: The Edwards SAPIEN Aortic Bioprosthesis European Outcome (SOURCE) Registry was designed to assess initial post commercial clinical transcatheter aortic valve implantation results of the Edwards SAPIEN valve in consecutive patients in Europe. Cohort 1 consists of 1038 patients enrolled at 32 centers. One-year outcomes are presented. Patients with the transapical approach (n=575) suffered more comorbidities than transfemoral patients (n=463) with a significantly higher logistic EuroSCORE (29% versus 25.8%; P=0.007). These groups are different; therefore, outcomes cannot be directly compared. Total Kaplan Meier 1-year survival was 76.1% overall, 72.1% for transapical and 81.1% for transfemoral patients, and 73.5% of surviving patients were in New York Heart Association (NYHA) class I or II at 1 year. Combined transapical and transfemoral causes of death were cardiac in 25.1%, noncardiac in 49.2%, and unknown in 25.7%. Pulmonary complications (23.9%), renal failure (12.5%), cancer (11.4%), and stroke (10.2%) were the most frequent noncardiac causes of death. Multivariable analysis identified logistic EuroSCORE, renal disease, liver disease, and smoking as variables with the highest hazard ratios for 1-year mortality whereas carotid artery stenosis, hyperlipidemia, and hypertension were associated with lower mortality. CONCLUSION: The SOURCE Registry is the largest consecutively enrolled registry for transcatheter aortic valve implantation procedures. It demonstrates that with new transcatheter aortic techniques excellent 1-year survival in high-risk and inoperable patients is achievable and provides a benchmark against which future transcatheter aortic valve implantation cohorts and devices can be measured.

A meta-analysis of proximal occlusion device outcomes in carotid artery stenting.

BACKGROUND: The clinical risk predictors for adverse events in carotid stenting using distal embolic protection devices are well established and include patient age and symptomatic status. The risk predictors for adverse events with proximal occlusion devices are not as well established. This study is a meta-analysis of available data on proximal occlusion devices to determine the risk predictors of adverse events in carotid stenting. METHODS: Study-specific results on 2,397 patients from six independent databases of two different proximal occlusion devices were meta-analyzed by an independent statistical analysis organization for predictors of 30-day major adverse clinical events including stroke, myocardial infarction, and death using random effects models. The primary endpoint was the composite of total stroke, myocardial infarction, and death at 30 days. RESULTS: The incidence of stroke was 1.71%. The incidence of myocardial infarction was 0.02%. The incidence of death was 0.40%. The composite primary endpoint at 30 days was 2.25%. Age and diabetic status were found to be the only significant independent risk predictors; however, total stroke rates remained below 2.6% in all subgroups, including symptomatic octogenarians. The other baseline demographic variables including patient gender, symptomatic status, and contralateral carotid occlusion were not found to be independent risk predictors. CONCLUSIONS: A meta-analysis of CAS procedures performed with proximal occlusion devices demonstrated a very low incidence of adverse events at 30 days. The only independent risk predictors were age and diabetes. Patient gender, symptomatic status, and other baseline characteristics were not found to be risk predictors for CAS using proximal occlusion devices.

European Registry of Carotid Artery Stenting: results from a prospective registry of eight high volume EUROPEAN institutions.

BACKGROUND: Carotid endarterectomy (CEA) is the standard revascularization therapy to prevent stroke in patients with carotid artery disease. Carotid artery stenting (CAS) could be considered a potential alternative in patients at high surgical risk. Recent clinical trials have challenged this concept due a relatively high incidence of post-CAS adverse events, which occurred in low volume centers. The aim of this study was to evaluate the outcomes associated with neuroprotected CAS in selected high volume centers. METHODS: From January 2007 to December 2007, 1,611 patients underwent neuroprotected CAS in eight European Centers. For each patients, clinical, procedural, and one month follow-up data from all patients have been collected. An independent clinical events committee adjudicated the events. RESULTS: Overall in hospital death was 0.06% (one patient), whereas in-hospital stroke was 0.49% (eight patients). Between hospital discharge and 30 days three additional patients died (0.18%) and 10 patients experienced a stroke (0.67%). Overall 30 days mortality was 0.24% (four patients) and stroke incidence 1.12% (18 patients). The 30 day stroke/death rate was 1.36%. CONCLUSIONS: CAS is a reasonable alternative to CEA to treat carotid artery atherosclerosis in well-experienced high volume centers. These data suggest that future prospective trials comparing CAS and CEA outcomes should include only centers highly experienced in both treatment modalities.

Thirty-day results of the SAPIEN aortic Bioprosthesis European Outcome (SOURCE) Registry: A European registry of transcatheter aortic valve implantation using the Edwards SAPIEN valve.

BACKGROUND: Transcatheter aortic valve implantation was developed to mitigate the mortality and morbidity associated with high-risk traditional aortic valve replacement. The Edwards SAPIEN valve was approved for transcatheter aortic valve implantation transfemoral delivery in the European Union in November 2007 and for transapical delivery in January 2008. METHODS AND RESULTS: The SAPIEN Aortic Bioprosthesis European Outcome (SOURCE) Registry was designed to assess the initial clinical results of the Edwards SAPIEN valve in consecutive patients in Europe after commercialization. Cohort 1 consists of 1038 patients enrolled at 32 centers. Patients who were treated with the transapical approach (n=575) suffered more comorbidities than the transfemoral patients (n=463), resulting in a significantly higher logistic EuroSCORE (29.1% versus 25.7%; P<0.001). Therefore, these groups are considered different, and outcomes cannot be compared. Overall short-term procedural success was observed in 93.8%. The incidence of valve embolization was 0.3% (n=3), and coronary obstruction was reported for 0.6% (n=6 cases). Incidence of stroke was 2.5% and similar for both procedural approaches. Thirty-day mortality was 6.3% in transfemoral patients and 10.3% in transapical patients. The occurrence of vascular complications was not a predictor of <30-day mortality in the transfemoral population. CONCLUSIONS: Technical proficiency can be learned and adapted readily as demonstrated by the short-term procedural success rate and low 30-day mortality rates reported in the SOURCE Registry. Specific complication management and refinement of patient selection are needed to further improve outcomes.

Data Recorded in Real Life Support the Safety of Nattokinase in Patients with Vascular Diseases.

Nattokinase (NK) is a serine protease enzyme with fibrinolytic activity. Even if it could be used for the treatment of several diseases, no data have been published supporting its use patients who underwent vascular surgery. In this study, we evaluated both the efficacy and the safety of nattokinase (100 mg/day per os) in patients admitted to vascular surgery. Patients were of both sexes, >18 years of age, with vascular diseases (i.e., deep vein thrombosis, superficial vein thrombosis, venous insufficiency), and naïve to specific pharmacological treatments (anticoagulants or anti-platelets). Patients were divided into three groups. Group 1: patients with deep vein thrombosis, treated with fondaparinux plus nattokinase. Group 2: patients with phlebitis, treated with enoxaparin plus nattokinase. Group 3: patients with venous insufficiency after classical surgery, treated with nattokinase one day later. During the study, we enrolled 153 patients (age 22-92 years), 92 females (60.1%) and 61 males (39.9%;), and documented that nattokinase was able to improve the clinical symptoms (p < 0.01) without the development of adverse drug reactions or drug interactions. Among the enrolled patients, during follow-up, we did not record new cases of vascular diseases. Attention to patients' clinical evolution, monitoring of the INR, and timely and frequent adjustment of dosages represent the cornerstones of the safety of care for patients administered fibrinolytic drugs as a single treatment or in pharmacological combination. Therefore, we can conclude that the use of nattokinase represents an efficient and safe treatment able to both prevent and treat patients with vascular diseases.

Real-world outcome of coronary bifurcation lesions in the drug-eluting stent era: results from the 4,314-patient Italian Society of Invasive Cardiology (SICI-GISE) Italian Multicenter Registry on Bifurcations (I-BIGIS).

BACKGROUND: Drug-eluting stents (DESs) introduction has somewhat renewed the issues of strategy and stenting technique for treatment of bifurcation lesions. In particular, concerns remain on extensive use of DESs, especially in the side branch, and on time of dual antiplatelet therapy (DAT) discontinuation, reflecting lack of pertinent long-term data. This study aimed to evaluate clinical safety and efficacy of different strategies for bifurcations treatment in a large observational real-world registry. METHODS: A multicenter, retrospective Italian study of consecutive patients undergoing bifurcation percutaneous coronary intervention between January 2002 and December 2006 was performed. The primary end point was the long-term rate of major adverse cardiac events (MACEs). The role of DAT length on outcome was also analyzed. RESULTS: A total of 4,314 patients (4,487 lesions) were enrolled at 22 independent centers. In-hospital procedural success rate was 98.7%. After median follow-up of 24 months, MACEs occurred in 17.7%, with cardiac death in 3.4%, myocardial infarction in 4.0%, target lesion revascularization in 13.2%, and stent thrombosis in 2.9%. Extensive multivariable analysis showed that MACEs were independently predicted by age, diabetes, renal failure, systolic dysfunction, multivessel disease, myocardial infarction at admission, restenotic lesion, bare-metal stent implantation, complex stenting strategy, and short duration of DAT. CONCLUSIONS: This large study based on current clinical practice in an unselected patient population presenting with bifurcation disease and submitted to percutaneous coronary intervention demonstrated favorable long-term clinical results in this challenging patient setting, especially when DESs, simple stenting strategy, and DAT for at least 6 months are used.

Heparin versus bivalirudin for carotid artery stenting using proximal endovascular clamping for neuroprotection: results from a prospective randomized study.

BACKGROUND: General recommendations indicate that, during a carotid artery stenting (CAS), sufficient unfractionated heparin (UFH) has to be given to maintain the activated clotting time between 250 to 300 seconds. Bivalirudin use is able to reduce postprocedural bleedings in percutaneous interventions when compared with UFH. The study purpose was to evaluate, in a randomized study, the safety and efficacy of bivalirudin versus heparin during CAS, using proximal endovascular occlusion (PEO) as a distal protection device. METHODS: From January 2006 to December 2009, 220 patients undergoing CAS using PEO have been randomly assigned to one of the study arms (control arm: 100 UI/kg UFH or bivalirudin arm: 0.75 mg/kg intravenous bolus and intraprocedural infusion at 1.75 mg/kg/h). RESULTS: Procedural success was achieved in all the patients. No episodes of intraprocedural thrombosis occurred. One major stroke occurred in the bivalirudin arm, and two minor strokes occurred, one in each group. A significant difference in the incidence of postprocedural bleedings was observed between the study groups; bivalirudin use was associated with reduced number of bleedings according to Thrombolysis In Myocardial Infarction criteria. CONCLUSIONS: The use of bivalirudin should be considered a safe and effective anticoagulation regimen during CAS, using PEO as a distal protection device. Bivalirudin use is associated with a reduced incidence of bleedings.

Carotid artery stenting in octogenarians using a proximal endovascular occlusion cerebral protection device: a multicenter registry.

BACKGROUND: Carotid stenting (CAS) has been proposed as an alternative to carotid endoarterectomy also in elderly patients with discrepant results. However, the use of proximal neuroprotection devices have not been evaluated in octogenarians. PURPOSE: The aim of this multicenter prospective registry was to demonstrate that CAS in octogenarians is safe and effective if performed in high-volume centers by experienced operators. METHODS: From July 2005 to May 2009, a total of 198 octogenarians patients, in three different institutions, were included in this registry. All patients underwent CAS using proximal endovascular occlusion device (Mo.Ma. device Invatec, Roncadelle, Italy). An independent neurologist evaluated all patients. The primary endpoint was death and stroke rate at 30 days. RESULTS: 198 octogenarians (135 men; mean age: 83.2 years) were included in the registry. 39.4% of the patients were symptomatic. Procedural success was 100%. In-hospital complications: Two minor and two major strokes (2.02%) occurred. No device-related complications and no serious access site complication were noted. Between discharge and 30-day follow-up, one patient died due to a cardiac arrest. The overall 30-day combined stroke/death rate was 2.52%, resulting in 1.61% event incidence in asymptomatic and 3.9% in symptomatic patients (P = ns). Logistic regression did not identify independent predictor of neurological events, except in the female gender. CONCLUSION: This multicenter prospective registry shows that CAS performed with proximal flow blockage is safe and feasible also in octogenarians. Thirty days death/stroke rates are similar to those of the overall population and within the International guidelines.

Safety and effectiveness of the INVATEC MO.MA proximal cerebral protection device during carotid artery stenting: results from the ARMOUR pivotal trial.

OBJECTIVE: The multicenter ARMOUR (ProximAl PRotection with the MO.MA Device DUring CaRotid Stenting) trial evaluated the 30-day safety and effectiveness of the MO.MA Proximal Cerebral Protection Device (Invatec, Roncadelle, Italy) utilized to treat high surgical risk patients undergoing carotid artery stenting (CAS). BACKGROUND: Distal embolic protection devices (EPD) have been traditionally utilized during CAS. The MO.MA device acts as a balloon occlusion "endovascular clamping" system to achieve cerebral protection prior to crossing the carotid stenosis. METHODS: This prospective registry enrolled 262 subjects, 37 roll-in and 225 pivotal subjects evaluated with intention to treat (ITT) from September 2007 to February 2009. Subjects underwent CAS using the MO.MA device. The primary endpoint, myocardial infarction, stroke, or death through 30 days (30-day major adverse cardiac and cerebrovascular events [MACCE]) was compared to a performance goal of 13% derived from trials utilizing distal EPD. RESULTS: For the ITT population, the mean age was 74.7 years with 66.7% of the cohort being male. Symptomatic patients comprised 15.1% and 28.9% were octogenarians. Device success was 98.2% and procedural success was 93.2%. The 30-day MACCE rate was 2.7% [95% CI (1.0-5.8%)] with a 30-day major stroke rate of 0.9%. No symptomatic patient suffered a stroke during this trial. CONCLUSIONS: The ARMOUR trial demonstrated that the MO.MA(R) Proximal Cerebral Protection Device is safe and effective for high surgical risk patients undergoing CAS. The absence of stroke in symptomatic patients is the lowest rate reported in any independently adjudicated prospective multicenter registry trial to date.

[SICI-GISE commuNity CAmpania survey doNna TAVI (INCANTA): perioperative and short-term outcome of transcatheter aortic valve implantation in women]. / SICI-GISE commuNity CAmpania survey doNna TAVI (INCANTA): outcome perioperatorio e a breve termine della procedura di impianto transcatetere di valvola aortica nelle donne.

BACKGROUND: Nowadays the prognostic role of gender as a relevant factor after transcatheter aortic valve implantation (TAVI) is still unfair, since available data in the literature are few and uneven. The aim of this survey was to collect acute and 30-day safety and efficacy clinical data in high- and intermediate-risk women, who underwent TAVI with new-generation devices, in the Campania Region. METHODS: All medium and high-volume TAVI centers in Campania have been invited to fulfill an online, ad-hoc questionnaire, collecting pre-, peri- and post-procedural data concerning female patients, treated between January and December 2016. RESULTS: 331 women (representing the 61% of the overall population treated; mean age 83 ± 7 years) underwent TAVI in the participating Campania centers. Age >80 years (72%), high surgical risk score (63%) and frailty (55%) were found to be the top three reasons for the TAVI choice. Overall, 95% of the procedures were performed by transfemoral approach with local anesthesia; the remaining 5% (16 cases) were conducted via transapical (14, 4%) and transaortic (2, 1%) accesses, under general anesthesia. Edwards Sapien 3 (Edwards Lifesciences, Irvine, CA, USA) and Medtronic Evolut R (Medtronic Inc., Minneapolis, MN, USA) were the most frequently implanted valves (146, 44% and 132, 43%, respectively). The questioned Centers reported a mean length of hospital stay of 5.5 ± 1.1 days, 1.6 ± 0.37 of which in a cardiac care unit. The most prevalent in-hospital complication was pacemaker implantation (15%), followed by life-threatening vascular complications (3%). The 30-day VARC-2 composite endpoint occurred in 7% of cases, all-cause death in 4%, and stroke in 1%. CONCLUSIONS: This survey, the first representative of women undergoing TAVI in Campania, appears to confirm the good safety and efficacy profile of this procedure, also in the high- and intermediate-risk settings, probably favored by a prevalent use of new-generation devices and a low rate prevalence of significant patient comorbidities.

Somatic DNA damage in interventional cardiologists: a case-control study.

Interventional cardiologists who work in cardiac catheterization laboratories are exposed to low doses of ionizing radiation that could pose a health hazard. DNA damage is considered to be the main initiating event by which radiation damage to cells results in development of cancer and hereditary disease. The aim of the present study was to assess the effects of chronic low-dose X-ray radiation exposure on somatic DNA damage of interventional cardiologists working in high-volume cardiac catheterization laboratories. For this analysis, we used peripheral lymphocytes and the assay for micronuclei (MNs), which is considered to be a reliable biological dosimeter for radiation exposure. We obtained peripheral blood from 62 physicians (mean age+/-se = 40.6+/-1.5 years): 31 interventional cardiologists (group I, exposed) and 31 age- and sex-matched clinical cardiologists (group II, nonexposed). Interventional cardiologists showed higher MN values (group I=20.5+/-1.6 vs. group II=12.8+/-1.3, P=0.001), although some overlap was apparent in the individual subject analysis. A correlation between years of professional activity and MN frequency value was detectable for interventional cardiologists (r=0.428, P=0.02) but not for clinical cardiologists (r=0.253, P=0.17). The results indicated that, overall, interventional cardiologists working in a high-volume catheterization laboratory have higher levels of somatic DNA damage when compared with clinical cardiologists working outside the catheterization laboratory. The amount of this damage varies and is only weakly related to the duration of professional exposure, which suggests that a dominant modulation of the underlying genetic substrate by environmental factors has a role in determining the harm in individual physicians.

Prevalence and Impact of Atrial Fibrillation in Patients With Severe Aortic Stenosis Undergoing Transcatheter Aortic Valve Replacement: An Analysis From the SOURCE XT Prospective Multicenter Registry.

OBJECTIVES: The aims of this study were to assess the epidemiology of atrial fibrillation (AF) in patients treated with transcatheter aortic valve replacement (TAVR) and included in the large prospective SOURCE XT (SAPIEN XT Aortic Bioprosthesis Multi-Region Outcome Registry) study and to evaluate their outcomes according to the presence of pre-existing or new-onset AF (NOAF) (defined as AF occurring within 30 days after TAVR). BACKGROUND: Data on the epidemiology and clinical impact of AF in patients undergoing TAVR are scant and limited to small retrospective studies. METHODS: The SOURCE XT study is a multicenter, prospective registry of consecutive patients treated with the SAPIEN XT valve at 99 sites in 17 countries. Follow-up was scheduled at discharge, 1 month, 1 year, and yearly thereafter. Patients (n = 2,706) were categorized according to the presence of pre-existing or NOAF. RESULTS: The prevalence of pre-existing AF was 35.6%, whereas NOAF occurred in 7.2% of patients. Both pre-existing AF and NOAF correlated with worse clinical outcomes compared with patients in sinus rhythm, including all-cause death, cardiac death, and bleeding events. NOAF was associated with higher rates of stroke at 2 years compared with sinus rhythm. Independent predictors of NOAF were age (hazard ratio: 1.1), New York Heart Association class III or IV (hazard ratio: 1.9), nontransfemoral access route (hazard ratio: 3), and balloon post-dilation (odds ratio: 1.6). No interaction was observed between any degree of post-implantation paravalvular leak and NOAF. CONCLUSIONS: In the large dataset of the SOURCE XT registry, the presence of either pre-existing or NOAF increased all-cause and cardiac mortality and bleeding events. NOAF was associated with increased stroke rates at long-term follow-up.

Impact on outcome of different types of carotid stent: results from the European Registry of Carotid Artery Stenting.

AIMS: Conflicting data exist on the impact on outcome of the use of different stent types during carotid artery stenting (CAS). The aim of this study was to evaluate clinical outcomes according to different carotid stent design among the population of the European Registry of Carotid Artery Stenting (ERCAS). METHODS AND RESULTS: The present study was conducted in 1,604 patients who underwent neuroprotected CAS in ERCAS. All types of commercially available carotid stent were used. Open-cell design stents were classified according to free cell area into <7.5 mm2 or >7.5 mm2. A total of 713 closed-cell, 456 hybrid-cell, 238 <7.5 mm2 open-cell, and 197 >7.5 mm2 open-cell stents were implanted. Overall, the 30-day stroke and death rate was 1.37%. At 30 days, 19 strokes occurred (1.18%): eight in the group of patients treated with a closed-cell (1.12%), two in those with a hybrid-cell (0.44%), three in those with a <7.5 mm2 open-cell (1.26%), and six in those treated with a >7.5 mm2 open-cell stent (3.05%) (p=0.045). CONCLUSIONS: Data of the present study suggest that, in the setting of neuroprotected CAS performed in high-volume centres by properly trained operators, the use of an open-cell design stent with a free cell area >7.5 mm2 may be associated with an increased 30-day stroke risk.