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Background: Conduction system pacing (CSP) and atrioventricular junction ablation (AVJA) improve outcomes in patients with symptomatic, refractory atrial fibrillation (AF). Superior approach (SA) from the pocket via axillary or subclavian vein has been proposed as an alternative to the conventional femoral venous access (FA) to perform AVJA. Objective: To assess the feasibility and safety of SA for AVJA performed simultaneously with CSP, and to compare this approach with FA. Methods: A prospective, observational study, enrolling consecutive patients with symptomatic, refractory AF undergoing simultaneous CSP and AVJA. Results: A total of 107 patients were enrolled: in 50, AVJA was primarily attempted with SA, in 69 from FA. AVJA with SA was successful in 38 patients (76.0%), while in 12 patients, a subsequent FA was required. AVJA from FA was successful in 68 patients (98.5%), while in one patient, a left‐sided approach via femoral artery was required. Compared with FA, SA was associated with a significantly longer duration of ablation (238.0 ± 218.2 vs. 161.9 ± 181.9 s; p =.035), a significantly shorter procedure time (28.1 ± 19.8 vs. 19.8 ± 16.8 min; p =.018), an earlier ambulation (2.7 ± 3.2 vs. 19.8 ± 0.1 h; p <.001), and an earlier discharge from procedure completion (24.0 ± 2.7 vs. 27.1 ± 5.1 h; p <.001). After a median follow‐up of 12 months, the rate of complications was similar in the two groups (2.0% in SA, 4.3% in FA; p =.483). Conclusion: Simultaneous CSP and AVJA with SA is feasible, with a safety profile similar to FA. Compared to FA, this approach reduces the procedure times and allows earlier ambulation and discharge. [ABSTRACT FROM AUTHOR]

Background: New cerebral infarcts (CIs) detected at magnetic resonance imaging (MRI) are reported after cardiac procedures. Clinical and procedural aspects are implicated as potential causal factors. The aim of this study was to evaluate the incidence of new CIs after coronary angiography and percutaneous coronary intervention according to the arterial access site.Methods: 180 patients undergoing elective coronary angiography were studied with cerebral MRI the day before and the day after the procedure. Unadjusted and propensity score (PS) analyses were performed comparing the occurrence of CIs in right radial (RR), left radial (LR) and transfemoral (TF) access groups.Results: New CIs were observed in 14 patients (7.8% of the total sample, one with neurological sequelae). CIs were detected in 15.5% vs 4.9% vs 3.3% of RR, LR and TF groups, respectively (p = .026). In PS adjusted analyses, the RR approach was associated with more CIs compared with the TF approach (odds ratio [OR] estimate from logistic regression adjusted by PS quartiles: 0.158; 95% confidence interval: 0.031 to 0.814; p = .027) and the LR approach (OR: 0.266; 95% confidence interval: 0.066 to 1.080; p = .064). In a secondary analysis, a comparison of RR vs non-RR approach (TF + LR) was performed, showing that post-procedural CIs were more frequent in the RR group (OR: 0.170; 95% confidence interval: 0.050 to 0.574; p = .004).Conclusions: Our study suggests that the RR approach may be associated with a higher rate of new CIs after coronary angiography compared with LR and TF approaches. [ABSTRACT FROM AUTHOR]

Purpose: To evaluate efficacy and safety of a new rotational atherectomy (RA), the Phoenix Atherectomy™ System, for the treatment of de novo and re-stenotic or occlusions atherosclerotic moderate-heavily lesions of the femoro-popliteal axis.Material and Methods: From January 2015 to August 2017, 52 patients with heavily calcified femoro-popliteal lesions causing severe stenosis or occlusions were enrolled in our center to be treated using Phoenix catheters. Primary endpoints of this study were acute efficacy and safety at 30 days. Secondary endpoints were freedom from restenosis and target lesion revascularization (TLR)/target vessel revascularization (TVR) at 1-, 6- and 12- months.Results: The mean lesion length was 9.2 cm (range 5-23 cm). The lesions were located in superficial femoral artery (SFA) in 61.5% (Fig. 1-A), in popliteal artery in 21.1% and involved femoral-popliteal axis in 15.4%. A primary technical success was achieved in 51/52 patients, with an optimal working channel after RA alone. Using Kaplan-Meyer analysis, primary vessel patency rates at 1, 6 and 12 -months was 96.1%, 86.5% and 76.9% respectively. Assisted primary patency at 1, 6- and 12 -months was 100%, 90.3% and 86.5% respectively.Conclusions: Recanalisation with the Phoenix Atherectomy System is simple and safe, with a high technical success rate. [ABSTRACT FROM AUTHOR]

Wound healing treated by larval therapy was widely used for centuries, but this practice leads to the decline since the advent of antibiotic era. The classic treatment of necrotic and infected ulcer is surgical debridement and to use different types of dressing for the healing. Nevertheless, larval therapy has been recently rediscovered as a viable treatment of necrotic infected wounds because more and more bacteria are resistant to the traditional therapeutic such as topical antimicrobial or silver-containing impregnated dressing. The mechanism of larval is the secretion of proteolytic enzymes which liquefies the necrotic lesions and the tissue is digested by the larvae. Maggots can quickly and efficiently debride necrotic lesions while leaving the viable tissue alone and promote the formation of healthy granulation tissue. Treatment involves laying the dressing containing the maggots on the necrotic wound for 5 or 6 days. After the dressing is removed and replaced by another one. Three or four applications were clinically beneficial for the patients. Larval therapy also decreases odour and pain and avoids surgical debridement. We present ours experience with larval therapy which was used on several patients. After several weeks of use, the larval therapy has improved the infected wound's healing without any surgical debridment. Moreover, it reduces the pain and edema. The first patient was a 89 years-old-man with a necrosis of the big toe. We realized a transmetatarsian amputation of the toe with a revascularization of the leg. After 5 days, we used larval therapy on the amputation level with good result. The second was a 59 years-old-man who was admitted for necrotic infected and chronic ulcer of the right food. The patient presented a right commun iliac artery's occlusion with occlusion of the superficial femoral and popliteal arteries. He has undergone an iliac stentgraft associated to femoro-popliteal reconstruction. At the fifteenth days postoperative, we decided to use larval therapy because of the non- evolution of the necrotic lesion. Several applications have been necessary to have healthy granulation tissue. The third patient was a 73years-old-women with a necrotic infected lesion of the right calf. She has gone an iliac and femoral stentgraft. Larval therapy was used on the necrotic and infected lesions. After four applications, we obtained clean ulcer and the lesion was treated by an antibacterial dressing. In conclusion we found larval theray to be effective for ulcers' debridement, easy to use and well accepted by patients. [ABSTRACT FROM AUTHOR]

Background: There is an increasing trend towards shorter hospital stays after transcatheter aortic valve implantation (TAVI), in particular for patients undergoing the procedure via transfemoral (TF) access. Preliminary data suggest that there exists a population of patients that can be discharged safely very early after TF-TAVI. However, current evidence is limited to few retrospective studies, encompassing relatively small sample sizes.Methods: The Feasibility And Safety of early discharge after Transfemoral TAVI (FAST-TAVI) registry is a prospective observational registry that will be conducted at 10 sites across Italy, the Netherlands and the UK. Patients will be included if they have been scheduled to undergo TF-TAVI with the balloon-expandable SAPIEN 3 transcatheter heart valve (THV; Edwards Lifesciences, Irvine, CA). The primary endpoint is a composite of all-cause mortality, vascular-access-related complications, permanent pacemaker implantation, stroke, re-hospitalisation due to cardiac reasons, kidney failure and major bleeding, occurring during the first 30 days after hospital discharge. Patients will be stratified according to whether they were high or low risk for early discharge (≤3 days) (following pre-specified criteria), and according to whether or not they were discharged early. Secondary endpoints will include time-to-event (Kaplan-Meier) analysis for the primary outcome and its individual components, analysis of the relative costs of early and late discharge, and changes in short- and long-term quality of life. Multivariate logistic regression will be used to identify factors that indicate that a patient may be suitable for early discharge.Discussion: The data gathered in the FAST-TAVI registry should help to clarify the safety of early discharge after TF-TAVI and to identify patient and procedural characteristics that make early discharge from hospital a safe and cost-effective strategy.Trial Registration: ClinicalTrials.gov Identifier: NCT02404467 (registration first received March 23rd 2015). [ABSTRACT FROM AUTHOR]

Several devices are available for infrainguinal endovascular therapy, with drug-eluting stents (DES) among the most promising. Bioresorbable vascular scaffolds (BVS) may further improve outcomes. We have liberally used in our practice coronary DES and BVS for infrainguinal endovascular therapy and hereby report our preliminary results. We conducted an observational study by retrospectively identifying characteristics of patients undergoing infrainguinal implantation of coronary DES or BVS. We compared the risk of major adverse events (MAE: death, amputation, or target vessel revascularization [TVR]) and components of MAE in the overall sample and after propensity matching. We included a total of 204 patients (207 limbs), 148 (72.5%) treated with DES and 56 (27.5%) with BVS. Bivariate analysis showed that TVR was less common in the DES group (41.9% vs 18.4%, P = .014). However, propensity-matched analysis showed nearly identical risks of MAE, amputation, TVR, or symptom burden with DES and BVS (all P > .05). In conclusion, the present pilot experience with coronary BVS suggests that they could provide acceptable results for infrainguinal endovascular procedures, comparable to those obtained by their metallic counterpart. [ABSTRACT FROM AUTHOR]

The effects of simulated microgravity on the static and dynamic properties of large arteries are still mostly unknown. The present study evaluated, using an integrated vascular approach, changes in structure and function of the common carotid and femoral arteries (CCA and CFA) after prolonged head-down tilt bed rest (HDTBR). Ten healthy men were enrolled in a 5-week HDTBR study endorsed by the Italian Space Agency (ASI). Arterial geometry, flow, stiffness, and shear rate were evaluated by ultrasound. Local carotid pulse pressure and wave reflection were studied by applanation tonometry. After five weeks of HDTBR, CFA showed a decrease in lumen diameter without significant changes in wall thickness (IMT), resulting in an inward remodeling. Local carotid pulse pressure decreased and carotid-to-brachial pressure amplification increased. The ratio of systolic-to-diastolic volumetric flow in CFA decreased, whereas in CCA it tended to increase. Indices of arterial stiffness and shear rate did not change during HDTBR, either in CCA or CFA. In summary, prolonged HDTBR has a different impact on CCA and CFA structure and flow, probably depending on the characteristics of the vascular bed perfused. [ABSTRACT FROM AUTHOR]

Background: The OBSERVANT study (Observational Study of Effectiveness of SAVR-TAVI Procedures for Severe Aortic Stenosis Treatment) showed that mortality at 1 year is similar after transfemoral transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR) for real-world propensity-matched patients with aortic stenosis at low and intermediate risk. We report the 5-year outcomes of the Italian OBSERVANT study., Methods and Results: The unadjusted enrolled population (N=7618) between December 2010 and June 2012 included 5707 patients on SAVR and 1911 patients on TAVR. The propensity score method was applied to select 2 groups with similar baseline characteristics. All outcomes were adjudicated through a linkage with administrative databases. The primary end points of this analysis were death from any cause and major adverse cardiac and cerebrovascular events at 5 years. The matched population had a total of 1300 patients (650 per group). The propensity score method generated a low and intermediate-risk population (mean logistic EuroSCORE 2: 5.1±6.2% versus 4.9±5.1%, SAVR versus transfemoral TAVR; P=0.485). At 5 years, the rate of 5 death from any cause was 35.8% in the surgical group and 48.3% in the transcatheter group (hazard ratio, 1.38; 95% CI, 1.12-1.69; P=0.002). Similarly, TAVR was associated with an increased risk of major adverse cardiac and cerebrovascular events as compared with SAVR (42.5% versus 54.0%; hazard ratio, 1.35; 95% CI, 1.11-1.63; P=0.003). The cumulative incidence of cerebrovascular events, myocardial infarction, and coronary revascularization were similar in the study groups at 5 years., Conclusions: The present results suggest that at 5 years, in a real-world population with severe aortic stenosis and at low and intermediate risk, suggest that SAVR is associated in with lower mortality and major adverse cardiac and cerebrovascular events rates than transfemoral TAVR performed using first-generation devices. These data need to be confirmed in randomized trials using new-generation TAVR devices.

Background: Contrast induced nephropathy (CIN) is a common complication of procedures that foresee the use of contrast media. Several risk factors have been identified as independent predictors of CIN, but, to date, no definitive data are available about the association between the angiographic approach and its development., Methods and Results: Our population included 4199 patients undergoing coronary angiography and/or PCI. CIN was defined as an absolute ≥0.5 mg/dl or a relative ≥25% increase in creatinine level at 24-48 h after the procedure without another clear cause for the acute kidney injury. The total incidence of CIN was 12.4%. We divided our population into two groups, according to the angiographic approach: transradial (TR) n = 1915 or transfemoral (TF) n = 2284. Patients treated with TR approach were more often males, with history of hypertension, and PCI, but less often diabetic, with previous myocardial infarction, coronary artery by-pass graft surgery and cerebrovascular accident. They had a higher ejection fraction, higher prevalence of PCI, elective indication but interestingly a lower amount of contrast volume. Patients treated with TR approach had higher platelets, Total, LDL and HDL cholesterol, but lower triglycerides, glycaemia and basal creatinine. No significant difference was observed between the two groups regarding the development of CIN (TR 13.2% vs TF 11.7%, p = 0.16). The absence of association between angiographic approach and the incidence of CIN was also confirmed at multivariate analysis after correction for baseline confounders (Adjusted OR [95% CI] = 1.2 [0.97-1.50], p = 0.09) and at subgroup analysis according to main risk factors for CIN. Similar results were obtained dividing our population according to propensity score tertiles: 1st Tertile CIN (TF 8.8% vs TR 8.9%), p = 0.95; OR (99% CI) = 1.01 (0.96-1.48), p = 0.95, 2nd Tertile CIN (TF 10.8% vs TR 12.4%), p = 0.35; OR (99% CI) = 1.17 (0.84-1.62), p = 0.35, and 3rd Tertile CIN (TF 15.6% vs TR 17.2%), p = 0.41; OR (99% CI) = 1.12 (0.85-1.48), p = 0.41., Conclusion: This is the first large study showing the absence of relationship between the angiographic access and the incidence of CIN., (Copyright © 2018. Published by Elsevier B.V.)

Background: New-generation transcatheter heart valves have been developed to reduce complications of transcatheter aortic valve implantation (TAVI). With this study we sought to compare procedural and 30-day outcomes of the new-generation repositionable Boston Scientific Lotus (Lotus) and the balloon-expandable Edwards Sapien 3 (ES3) transcatheter heart valves., Methods: A total of 315 patients with severe symptomatic aortic stenosis undergoing transfemoral TAVI with Lotus or ES3 included in two large Italian registries were considered for this analysis. After propensity matching, 93 matched pairs of patients were included. Outcomes were evaluated according to Valve Academic Research Consortium-2 definition at discharge and 30 days., Results: There were no differences in baseline characteristics, except for lower mean aortic gradient and larger mean aortic annulus in the ES3-treated patients. Valve Academic Research Consortium-2 defined device success was high and comparable between groups (97.8 for Lotus vs. 98.9% for ES3, P = 0.09). The frequency of moderate/severe paravalvular leak was low and similar for both devices (2.2 vs. 1.1%, P = 0.10). At 30 days, both groups showed low all-cause mortality (5.4 vs. 1.1%, P = 0.10) and rates of disabling stroke (3.2 vs. 1.1%, P = 0.31). New pacemaker implantation was more common after Lotus deployment (31.7 vs. 10.5%, P < 0.001)., Conclusion: Transfemoral TAVI with both Lotus and ES3 resulted in favorable clinical and hemodynamic procedural and 30-day outcomes. Rates of significant paravalvular leak were low with both devices. The Lotus valve was associated with higher risk of pacemaker implantation.

Background: Safety and efficacy of radial and femoral access for coronary angiography performed by cardiology fellows remain to be evaluated., Methods: In this multicenter prospective study, cardiology fellows selected the access site (among femoral, right and left radial artery) for coronary angiography. All bleeding events related to the access site and all complications (a composite of all bleedings and artery occlusion) were the co-primary safety end points. Success for each access site, procedural and radiological times and single components of primary outcome were the secondary ones., Results: Overall, 201 patients were enrolled. Fellows chose right radial, left radial or femoral access in 164 (82%), 20 (10%) and 17 (8%) cases, respectively. All-cause bleedings were lower in radial cohort (4 vs. 19%; P = 0.001) mainly driven by minor bleedings (4 vs. 18%, P = 0.012). Also, overall complications were less frequent with the radial approach (18 vs. 30%, P = 0.03) and radial artery occlusion did not differ between right vs. left side (4 vs. 5%, P = 0.76). Procedural time (minutes) was similar between radial and femoral site (23 ± 9 vs. 22 ± 10, P = 0.91), as well as time of X-ray exposure (6 ± 3 vs. 4 ± 2, P = 0.11), DAP (Gy/cm: 17 ± 11 vs. 18 ± 12, P = 0.74) and amount of contrast medium (ml: 106 ± 81 vs. 84 ± 43, P = 0.89). Success for access was significantly higher with radial artery (89 vs. 71%, P = 0.004)., Conclusion: Radial artery is the most exploited access by cardiologist fellows, leading to reduction in minor bleedings and higher success compared with femoral access. No differences in procedural time and radiation exposures were recorded.

Aim: The aim of this paper was to report outcomes of endovascular aneurysm repair with percutaneous femoral access (pEVAR) using Prostar XL and Proglide closure systems (Abbot Vascular, Santa Clara, CA, USA), from the multicenter Italian Percutaneous EVAR (IPER) registry., Methods: Consecutive patients affected by aortic pathology treated by EVAR with percutaneous access (pEVAR) between January 2010 and December 2014 at seven Italian centers were enrolled in this multicenter registry. All the operators had an experience of at least 50 percutaneous femoral access procedures. Data were prospectively collected into a dedicated online database including patient's demographics, anatomical features, intra- and postoperative outcomes. A retrospective analysis was carried out to report intraoperative and 30-day technical success and access-related complication rate. Uni- and multivariate analyses were performed to identify factors potentially associated with an increased risk of percutaneous pEVAR failure., Results: A total of 2381 accesses were collected in 1322 patients, 1249 (94.4%) male with a mean age of 73.5±8.3 years (range 45-97). The overall technical success rate was 96.8% (2305/2381). Major intraoperative access-related complications requiring conversion to surgical cut-down were observed in 3.2% of the cases (76/2381). One-month pEVAR failure-rate was 0.25% (6/2381). Presence of femoral artery calcifications resulted to be a significant predictor of technical failure (OR: 1.69; 95% CI: 1.03-2.77; P=0.036) at multivariate analysis. No significant association was observed with sex (P=0.28), obesity (P=0.64), CFA diameter (P=0.32), level of CFA bifurcation (P=0.94) and sheath size >18 F (P=0.24). The use of Proglide was associated with a lower failure rate compared to Prostar XL (2.5% vs. 3.3%) despite not statistically significant (P=0.33)., Conclusion: The results of the IPER registry confirm the high technical success rate of percutaneous EVAR when performed by experienced operators, even in presence of demanding anatomies. Femoral calcification represents the only predictor of percutaneous access failure.

Objectives: The aim of this prospective registry was to evaluate the safety and efficacy at 2-year follow-up of the use of drug-eluting balloons (DEBs) for the treatment of superficial femoral artery (SFA) in-stent restenosis (ISR)., Background: The use of DEBs for the treatment of SFA ISR is associated with a satisfactory primary patency rate at 1 year, but no data are available for longer follow-up. Unfortunately, when DEBs were used to treat SFA de novo lesions, the occurrence of restenosis increased by 50% between the first and the second years of follow-up., Methods: From December 2009 to December 2010, 39 consecutive patients underwent percutaneous transluminal angioplasty of SFA ISR at our institution (Clinica Montevergine, Mercogliano, Italy). All patients underwent conventional SFA percutaneous transluminal angioplasty and final post-dilation with paclitaxel-eluting balloons (IN.PACT, Medtronic Inc., Minneapolis, Minnesota). Patients were evaluated for up to 24 months., Results: During follow-up, 1 patient died of heart failure and another of sudden death, for a 2-years rate of cardiovascular mortality rate of 5.12 %. The primary patency rate at 2 years was 70.3% (11 of 37 patients experienced restenosis recurrence at 2-year follow-up). The treatment of complex ISR lesions (classes II and III) was associated with an increased rate of recurrent restenosis compared with class I (33.3 % and 36.3 % vs. 12.5%; p = 0.05)., Conclusions: The data suggest that adjunctive use of DEBs for the treatment of SFA ISR is a safe and effective therapeutic strategy up to 2 years of follow-up., (Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Transcatheter aortic valve implantation (TAVI) represents a promising therapeutic option for patients affected by severe aortic stenosis, but it is currently associated with high costs. Therefore, the assessment of its economic impact becomes urgent to support decision-makers' choices about its use, patient access to treatment and reimbursement mechanisms., Methods: A retrospective, observational, single-center (the teaching hospital located in Bologna, Italy) study was conducted. All patients with severe symptomatic aortic stenosis undergoing TAVI during the enrolment period (February 2008-August 2010) were included. The procedures were performed with both bioprostheses approved for clinical use and through different vascular access: CoreValve transfemoral (CV-TF), CoreValve transsubclavian (CV-TS), Edwards Sapien transapical (ES-TA), Edwards Sapien transfemoral (ES-TF). Costs of the whole index hospitalization have been calculated from the hospital perspective. Healthcare resource consumption was measured at patient level and assessed using unit costs (micro-costing approach)., Results: Overall, 87 consecutive patients (48 CV-TF, 12 CV-TS, 20 ES-TA, 7 ES-TF) were included in the study. They presented a high-risk profile (age 83.3 ± 5.4 years; logistic EuroSCORE 23.3 ± 12.3%) and important comorbidity. In-hospital mortality was 3.4%. Total cost of hospitalization was, on average, €35.841 (range €27.267-69.744) of which 68% was attributable to the procedure. A huge variation in costs was observed among different treatment groups. Patients treated with transfemoral implant (CV-TF: €33.977; ES-TF: €31.442) were on average less expensive than others (CV-TS: €37.035; ES-TA: €41.139)., Conclusions: Our findings show that treating patients with TAVI places a heavy burden on hospital budget. Hence, due to the shortage of financial resources, affordability of TAVI requires further attention.

Objectives: The aim of this study was to analyze the short-term outcomes after transcatheter aortic valve implantation with the Edwards Sapien THV (ESV), compared with the Sapien XT THV (SXT) (Edwards Lifesciences, Irvine, California)., Background: The SXT has been recently commercialized in Europe, but there are no studies analyzing the efficacy and safety of SXT, compared with ESV., Methods: All consecutive patients (n = 120) who underwent transcatheter aortic valve implantation in our center via the transfemoral approach with either ESV (n = 66) or SXT (n = 54). Valve Academic Research Consortium endpoints were used., Results: Mean age was 80 ± 8 years, and mean Logistic-European System for Cardiac Operative Risk Evaluation was 24.9 ± 17.0. The ilio-femoral artery minimal lumen diameter was smaller in patients treated with the SXT (7.27 ± 1.09 mm vs. 7.94 ± 1.08 mm, p = 0.002). Device success was high in both groups (96.3% vs. 92.4%, p = 0.45). Major vascular events were 3-fold lower in the SXT group (11.1% vs. 33.3%, relative risk: 0.40, 95% confidence interval: 0.28 to 0.57; p = 0.004). Life-threatening and major bleeding events were not significantly different between groups (18.5% vs. 27.3% and 35.2% vs. 40.9%, respectively). The SXT group had a lower 30-day Valve Academic Research Consortium combined safety endpoint (20.4% vs. 45.5%; relative risk: 0.44, 95% confidence interval: 0.24 to 0.80; p = 0.004). The 30-day mortality was 1.7% (n = 2). At 30 days, mean transaortic gradient was approximately 10 mm Hg in both groups and the aortic regurgitation was mild-to-moderate in 70.2% of SXT and 76.3% of ESV., Conclusions: The new SXT valve has the same short-term performance as the ESV but seems to be associated with a lower risk of major vascular complications and thus has a broader clinical application., (Copyright © 2011 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: Our aim was to assess clinical outcome after transcatheter aortic valve implantation (TAVI) performed with the 2 commercially available valves with 3 delivery approaches selected in a stepwise fashion., Background: Limited data exist on the results of a comprehensive TAVI program using different valves with transfemoral, transapical, and transaxillary approaches for treatment of severe aortic stenosis., Methods: We report 30-day and 6-month outcomes of high-risk patients consecutively treated in a single center with either the Medtronic-CoreValve (MCV) (Medtronic, Minneapolis, Minnesota) or Edwards-SAPIEN valve (ESV) (Edwards Lifesciences, Irvine, California) delivered via the transfemoral or transaxillary approaches and ESV via the transapical approach., Results: A total of 137 patients underwent TAVI: 107 via transfemoral (46 MCV and 61 ESV), 15 via transaxillary (12 MCV and 3 ESV), and 15 via transapical approach. After the transfemoral approach, the procedural success rate was 93.5%, and major vascular complication rate was 20.6%. No intra-procedural deaths occurred. The procedural success rates of transapical and transaxillary approaches were 86.6% and 93.3%, respectively. The 30-day mortality rate was 0.9% in transfemoral group and 13.3% in transapical, and no deaths occurred after transaxillary access. Cumulative death rate at 6 months was 12.2% in transfemoral, 26.6% in transapical, and 18.2% in transaxillary groups. At multivariable analysis, logistic European System for Cardiac Operative Risk Evaluation, body surface area, and history of cerebrovascular disease were significantly associated with an increased risk of major adverse cardiac and cerebrovascular events., Conclusions: Routine TAVI using both MCV and ESV with a selection of approaches is feasible and allows treatment of a wide range of patients with good overall procedural success rates and 30-day and 6-month outcomes., (Copyright © 2010 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Transradial access (RA) is associated with less complications and is preferred by patients. Vascular closure devices (VCDs) may improve discomfort and may reduce complications associated with transfemoral access. Aim was to evaluate complications and discomfort associated with percutaneous coronary procedures employing RA or VCDs., Methods: We enrolled 1492 consecutive patients who underwent percutaneous coronary procedures with RA (604 procedures), femoral approach with manual compression (MC) (276 procedures), or with either Angioseal (311 procedures) or Starclose (301 procedures) closure device. Discomfort was assessed using procedure-specific questions. Major vascular complications were evaluated during hospitalization., Results: RA significantly reduced major complications (0.7%) compared to either the MC (2.9%, p=0.03) or the VCDs (Starclose 2.7%, Angioseal 3.9%, p=0.003). There were no significant differences in major complications between MC and either the Angioseal or the Starclose. At multivariate analysis the RA was predictor of reduced complications (OR 0.26, 95% CI 0.08-0.85, p=0.03 vs MC, and OR 0.19, 95% CI 0.07-0.57, p=0.003 vs VCDs). The RA was associated with a significant reduction in procedural discomfort with 44.2% of patients referring no discomfort (p<0.0001). Starclose and Angioseal were better tolerated than MC (27.8%, 29.3% and 8.9% patients respectively without discomfort, p<0.0001)., Conclusions: RA is associated with a significant reduction in major vascular complications compared to femoral approach even if two different VCDs are employed. VCDs are better tolerated than MC but the RA was associated with the lowest discomfort.

Aim: The application of a vascular hemostasis system is a specialistic competence that could be charged to a cardiology nurse upon formal recognition of the acquired skill., Method: Haemostasis systems are routinely implemented by cardiology nurses. To officially recognize this skill a course was organized with two lectures, practical training and supervised practice., Results: 8 nurses attended the course and after the accreditation each introduced 150 Angio-Seals without relevant complications. Each minor problem is routinely discussed to exclude any malpractice., Conclusions: Certification of new skills is feasible and nurses' skills can be formally recognized with specific courses.