Future of left atrial appendage interventions.

Percutaneous left atrial appendage occlusion (LAAO), currently recognized as a procedure with relatively low risk, is increasingly being adopted in clinical practice. However, due to the preventive nature of the procedure and the necessity to compare it with newer and safer oral anticoagulants, further optimization is required to address remaining challenges. These latter include acquiring comprehensive data on safety and efficacy, establishing standardized pre-procedural planning, and simplifying procedural process. Consequently, we have provided an overview that encompasses future opportunities for enhancing procedural safety and efficacy, thereby establishing LAAO as the mainstream strategy for stroke and systemic embolism prevention in patients with atrial fibrillation and absolute contraindications to anticoagulant drugs.

Acute Kidney Injury in Patients with Acute Myocardial Infarction Undergoing Percutaneous Coronary Intervention: The Role of Vascular Access Site.

Background: in patients undergoing percutaneous coronary interventions (PCI), radial access should be favoured over femoral access as it reduces the risk of vascular complications and bleeding. Furthermore, a preventive role of radial access in the occurrence of acute kidney injury (AKI), mainly mediated by the reduction of bleeding and cholesterol crystal embolization into renal circulation, has been investigated in several studies, yielding conflicting results. Methods: we designed a retrospective study to appraise the effect of the use of a vascular access site on the occurrence of AKI in a cohort of 633 patients with acute myocardial infarction treated by PCI at our centre from 2018 to 2020. Results: after propensity score adjustment, radial access was associated with a reduced, albeit statistically not significant, incidence of AKI (14.7% vs. 21.0%; p = 0.06) and major bleeding (12.5% vs. 18.7%; p = 0.04) as compared to femoral access. At multivariate analysis, femoral access was an independent predictor of AKI, together with in-hospital occurrence of BARC 3-5 bleeding, Killip class >1 at presentation, female gender, baseline eGFR <60 mL/min, and baseline haemoglobin <12 g/dL. Conclusions: although limited by the observational design, our study supports the hypothesis that radial access may exert a protective role on the occurrence of AKI in patients with acute myocardial infarction undergoing PCI.

In-hospital outcomes of Portico transcatheter aortic valve replacement with the FlexNav as compared to the first-generation delivery system.

Introduction: Technological advancements in transcatheter heart valve platforms are essential in order to achieve high standards of efficacy and safety in transcatheter aortic valve replacement (TAVR). Aim: To evaluate the performance of the new version of the Portico valve delivery system (FlexNav) as compared to the first-generation device. Material and methods: In this single-center, observational study consecutive patients undergoing Portico valve implantation with the new FlexNav delivery system (DS) were compared with patients treated with the first-generation delivery system (1st gen DS). In-hospital outcomes were self-adjudicated according to the Valve Academic Research Consortium-3 definition. Results: Fifty patients were included in this study; 22 were treated with the FlexNav DS and the remaining patients with the 1st gen DS. Clinical characteristics were similar between groups, except for older age (82.6 ±3.6 vs. 80.7 ±3.8; p = 0.07) and higher prevalence of female gender (68.2% vs. 39.3%; p = 0.04) in the FlexNav DS group as compared to the 1st gen DS group, respectively. We observed similar rates of procedural success but higher rate of moderate-to-severe paravalvular leak in the 1st gen DS as compared to FlexNav DS group (28.6% vs. 4.6%; p = 0.03); major vascular complications were reduced, although not significantly, in the FlexNav DS as compared to the 1st gen DS group (4.5% vs. 10.7%; p = 0.64). Conclusions: Our data suggest that the FlexNav DS, thanks to its lower profile and enhanced stability during valve deployment, might be associated with reduced rates of vascular complications and moderate to severe paravalvular leak, thus improving procedural results.

Glycoprotein IIb/IIIa Inhibitors May Modulate the Clinical Benefit of Radial Access as Compared to Femoral Access in Primary Percutaneous Coronary Intervention: A Meta-Regression and Meta-Analysis of Randomized Trials.

OBJECTIVES: Several randomized controlled trials (RCTs) consistently reported better clinical outcomes with radial as compared to femoral access for primary percutaneous coronary intervention (PCI). Nevertheless, heterogeneous use of potent antiplatelet drugs, such as Gp IIb/IIIa inhibitors (GPI), across different studies could have biased the results in favor of radial access. We performed an updated meta-analysis and meta-regression of RCTs in order to appraise whether the use of GPI had an impact on pooled estimates of clinical outcomes according to vascular access. METHODS: We computed pooled estimates by the random-effects model for the following outcomes: mortality, major adverse cardiovascular events (death, myocardial infarction, stroke, and target vessel revascularization), and major bleedings. Additionally, we performed meta-regression analysis to investigate the impact of GPI use on pooled estimates of clinical outcomes. RESULTS: We analyzed 14 randomized controlled trials and 11090 patients who were treated by radial (5497) and femoral access (5593), respectively. Radial access was associated with better outcomes for mortality (risk difference 0.01 (0.00, 0.01), p=0.03), MACE (risk difference 0.01 (0.00, 0.02), p=0.003), and major bleedings (risk difference 0.01 (0.00, 0.02), p=0.02). At meta-regression, we observed a significant correlation of mortality with both GPI use (p=0.011) and year of publication (p=0.0073), whereas no correlation was observed with major bleedings. CONCLUSIONS: In this meta-analysis, the use of radial access for primary PCI was associated with better clinical outcomes as compared to femoral access. However, the effect size on mortality was modulated by GPI rate, with greater benefit of radial access in studies with larger use of these drugs.

One-year outcome from an all-comers population of patients with ST-segment elevation myocardial infarction treated with biolimus-eluting stent with biodegradable polymer.

OBJECTIVES: To evaluate the performance of biolimus-eluting stent (BES) in patients with ST-elevation myocardial infarction (STEMI) undergoing percutaneous coronary intervention (PCI) in a real world clinical scenario. BACKGROUND: Randomized studies suggest that the BES with biodegradable polymer is more effective and safe than early generation coronary stents in patients with STEMI. METHODS: We included all consecutive STEMI patients undergoing PCI in this prospective, multicenter registry. The primary endpoint of the study was the rate of major adverse cardiac events (MACE), a composite of cardiac death, recurrent myocardial infarction and ischemia-driven target vessel revascularization at 1-year follow-up. RESULTS: Between June and December 2012 we enrolled 311 STEMI patients. The primary endpoint occurred in 3.2% (95% confidence interval: 1.6-5.8) of patients: cardiac death, re-infarction, and ischemia-driven TVR occurred in 2.3%, 1.3%, and 0.6% of patients, respectively. One-year MACE-free survival was 96.8% ± 1.0%. CONCLUSIONS: In a real-world cohort of STEMI patients undergoing PCI, the use of BES is associated with good 1-year clinical outcome. These results confirm and expand previous findings showing the efficacy and safety of BES in the setting of randomized trials.

Safety and feasibility of iliac endovascular interventions with a radial approach. Results from a multicenter study coordinated by the Italian Radial Force.

BACKGROUND: Percutaneous angioplasty of lower limb disease is commonly performed with a transfemoral access. In the coronary field, a transradial approach has shown to reduce access-site bleeding and adverse clinical events. This route has not yet been well studied for the majority of peripheral interventions, like those involving the iliac arteries. In this study we sought to evaluate the feasibility and safety of this approach for iliac interventions. METHODS: Multicenter study was performed at high-volume centers with experience in transradial percutaneous interventions. Primary endpoint of the study was procedural success; secondary endpoints included in-hospital bleeding, 1-month freedom from adverse events and the rate of radial occlusion. Feasibility of this technique was evaluated by recording procedural and fluoroscopy time and contrast load. RESULTS: A total of 149 patients from 5 centers were enrolled. The population had a medium risk profile, with 48% of patients having TASC 2 or 3 lesions. Procedural success was achieved in 98.7% of the population, and we did not register in-hospital complications, including both vascular access site and procedural-related complications. An ancillary transfemoral approach was used in 13% of patients. One-month freedom from symptoms was achieved in 97.3% of patients, and the rate of radial occlusion was 2.7%. Major determinants of an unsuccessful procedure were the use of normal 6 or 7-Fr introducer with guiding catheter, TASC D lesion attempt, lesion length>30 mm and total occlusion. CONCLUSIONS: A transradial approach for iliac disease may be a feasible and safe alternative to the transfemoral route in experienced hands, in the light of significant technical improvements and dedicated devices.

Radial approach for percutaneous coronary interventions on chronic total occlusions: technical issues and data review.

OBJECTIVE: To overview the scientific data and the technical details regarding percutaneous coronary interventions (PCI) on chronic total occlusions (CTO) by radial approach. BACKGROUND: Trans-femoral approach is commonly regarded as the standard for PCI on CTO. METHODS: A systematic search in Medline and in the main international websites was realized. Key data were extracted and analyzed using standard meta-analytic techniques. Bench test assessment of compatibility between different combinations of interventional devices (required for CTO recanalization techniques) and the following guiding catheters was performed: 5 Fr, Sheathless 6.5 Fr, 6 Fr, Sheathless 7.5 Fr and 8 Fr. RESULTS: No prospective randomized study was found, whereas 13 observational studies on 3,501 CTOs treated by radial approach were identified. Overall, the crossover to femoral access rate ranged between 0 and 5.8%. Access site complications were noted in <1% of cases and in-hospital major adverse events were reported in 0-3.8% of patients. PCI success was significantly influenced by the learning curve: In the five studies comparing the success rates between a first and a later period of practice, a significant improvement was observed (OR, 95% CI: 0.30, 0.39-0.51; P < 0.001). The technical details relevant to approach a CTO by transradial access are discussed, and the original results of bench tests provide details regarding the compatibility of various CTO recanalization techniques with specific guiding catheter sizes. CONCLUSIONS: The transradial access represents a promising alternative to trans-femoral access to treat patients undergoing CTO PCI in high-volume transradial centres. The presented data may be useful to plan transradial PCI attempts on CTO lesions.

Impact of operator experience and wiring technique on procedural efficacy of trans-radial percutaneous chronic total occlusion recanalization performed by dedicated radialists.

BACKGROUND: The efficacy of trans-radial approach (TRA) in chronic total occlusions (CTO) percutaneous coronary interventions (PCI) is not well established. Thus, we sought to review the feasibility and long-term results of TRA for CTO PCI performed by dedicated TRA operatorsof our center. METHODS: CTO PCI performed by dedicated radialists were considered. Primary end-points were "PCI success" (stent implantation with residual stenosis < 20% and TIMI 3) and "patient success" (PCI success in a first or second attempt). Vascular complications and major adverse cardiac events (MACE) were also assessed. Procedures were divided into: Period 1 - no systematic adoption of TRA nor systematic wire selection, and Period 2 - systematic TRA with stepwise wire selection. The starting guidewire was initially an intermediate wire (Period 2a), and, thereafter, a tapered soft polymeric guidewire (Period 2b). RESULTS: Two operators performed 167 TRA PCI on CTO in 158 patients. PCI success rate was 74.3% and patient success rate was 78.5%. Drug-eluting stents were implanted in 95.1% of successful procedures. One (0.6%) patient had a (minor) vascular complication. After a mean follow-up of 580 days, 93.7% of patients were free from MACE. PCI success (57.1% in Period 1 vs. 76.5% in Period 2a vs. 80.5% in Period 2b, p = 0.029) and patient success (62.5% in Period 1 vs. 77.8% in Period 2a vs. 86.1% in Period 2b, p = 0.025) significantly improved during the study. CONCLUSIONS: CTO PCI by TRA is safe and feasible. Its efficacy seems to be strongly dependenton operator experience with CTO techniques and may be influenced by the strategy of guidewire selection.

Resolute zotarolimus-eluting stent to treat bifurcated lesions according to the provisional technique: a procedural performance comparison with sirolimus- and everolimus-eluting stents.

OBJECTIVES: Different drug-eluting stents (DES) may have different performance in bifurcation PCI. Thus, we compared the performance of a novel zotarolimus-eluting stent (ZRS) with that obtained using two other DES in bifurcation PCI. METHODS AND RESULTS: Consecutive patients with bifurcated lesions undergoing DES implantation were treated by a provisional approach with sirolimus-eluting stent (SES) or everolimus-eluting stent (EES) during a former period, and then by ZRS in a second period. The PCI procedural details were prospectively recorded and angiographic results were evaluated by a 3-dimensional quantitative coronary analysis software. Primary procedural end-point was "side-branch (SB) trouble" (occurrence, after MV stenting, of: SB TIMI flow<3 or need of specific wires for SB rewiring, or failure to re-wire/dilate the SB). Primary angiographic end-point was post-PCI minimal-lumen-diameter at SB-ostium. During the study, 225 patients were enrolled and treated by ZRS (n=75), by SES (n=75) or by EES (n=75). Among procedural characteristics, "SB trouble" occurred in 4% of patients treated by ZRS, a figure significantly lower compared to SES (16%, P=0.014) and non-significantly lower compared to EES (11%, P=0.12). At multivariable analysis, DES type, pre-PCI SB flow <3 and bifurcation complexity were the only predictors of "SB trouble". After the procedure, minimal-lumen-diameter at SB ostium was significantly larger with ZRS compared to SES (1.94 vs. 1.64 mm, P=0.008) and similar to that of EES. CONCLUSIONS: ZRS is associated to improved performance and SB angiographic results compared to SES. These results support the hypothesis that DES selection may influence the procedural course and the acute angiographic result of bifurcation PCI.

One-year outcomes of consecutive patients treated by Endeavor zotarolimus and Resolute zotarolimus stents: the impact of polymer coating in drug-eluting stent technology.

BACKGROUND: Polymer-coating represents a key component of drug-eluting stent (DES) technology and its possible impact on vessel-wall healing is a matter of debate. The clinical impact of different polymer-coating may be assessed by comparing the outcome of patients treated by DES having the same stent platform and drug, and differing in the polymer. Thus, we compared the clinical outcome of patients treated by Endeavor Zotarolimus-eluting stent (E-ZES) and Resolute Zotarolimus-eluting stent (R-ZES) as they differ in the polymer-coating only. METHODS: At our Institution, E-ZES was available during a first period and then it was substituted by the R-ZES during a second period. Clinical, angiographic, and procedural data were prospectively collected. Clinical follow-up was prospectively obtained up to 1-year. Primary endpoint was the occurrence of major adverse cardiac events (MACE) at 12-month. RESULTS: A total of 467 patients undergoing percutaneous coronary intervention were enrolled: 233 patients treated with E-ZES and 234 with R-ZES. Patients treated by R-ZES had similar clinical characteristics and worse angiographic characteristics compared with those treated by E-ZES. At 12-month follow-up, MACE rate was significantly lower in the R-ZES group compared with E-ZES group (4.2% vs. 14.6%; P < 0.01). This difference was due to nonsignificantly lower rates of death and myocardial infarction and to significant lower rate of target-lesion-revascularization (R-ZES 3.4% vs. E-ZES 10.3%, P < 0.01). CONCLUSIONS: The results of this study suggest that the clinical outcome of patients treated by DES differing for the polymer coating only may be different. Polymer coating is a pivotal, probably underrated, component of DES technology which may influence the clinical performance of DES.

Management and timing of access-site vascular complications occurring after trans-radial percutaneous coronary procedures.

BACKGROUND: Access-site vascular complications (ASVC) in patients undergoing trans-radial coronary procedures are rare but may have relevant clinical consequences. Data regarding the optimal management of radial-access-related ASVC are lacking. METHODS: During a period of 6 years we prospectively collected ASVC. ASVC were defined as any complication requiring ultrasound examination or upper limb angiography. ASVC were categorized according to the timing of diagnosis: "very early" (in the cath lab), "early" (after cath lab discharge, but during the hospital stay) and "late" (after hospital discharge). The need of surgery (primary end-point) and the development of neurological hand deficit (secondary end-point) were assessed. RESULTS: Fifty-seven radial-artery related ASVC were collected. ASVC diagnosis was obtained by upper limb angiography in 25 patients (44%) and by Doppler in 32 patients (56%). Surgery was required in 6 cases (11%), the remaining patients receiving successful conservative management (which included prolonged local compression). Three patients (who received surgery) exhibited a mild neurological hand deficit in the follow-up. Need for surgery differed significantly according to timing of diagnosis as it occurred in 1 of 26 patients (3.8%) with "very early" diagnosis, in 1 of 21 patients (4.8%) with "early" diagnosis, and in 4 of 10 patients (40%) with "late" diagnosis (p=0.026). CONCLUSIONS: ASVC are diagnosed with different timing after trans-radial procedures. Conservative management including local compression allows successful management in the majority of ASVC. Prompt recognition is pivotal as late diagnosis is associated to the need for surgery.

Baseline inflammatory status and long-term changes in renal function after percutaneous renal artery stenting: a prospective study.

OBJECTIVES: To investigate a possible independent predictive role of systemic inflammation markers on renal function after renal artery stenting. BACKGROUND: An elevated baseline serum creatinine has previously been shown to be the strongest predictor of improved renal function after percutaneous renal artery stenting. The inflammatory system is implicated in every stage of chronic kidney disease, and we hypothesized an additional value of markers of systemic inflammation in predicting response after renal artery stenting. METHODS: This single center, prospective study includes 62 consecutive patients with chronic kidney disease at stage ≥ 3 or resistant hypertension who underwent stent placement for 74 angiographically significant atherosclerotic renal lesions. Inflammatory markers, including serum C-reactive protein (CRP), erythrocyte sedimentation rate, and white blood cell count were determined prior to renal angioplasty and related to changes in renal function at follow-up. RESULTS: Six-month clinical follow up was completed in 57 patients. Overall, median serum creatinine concentration exhibited a non significant reduction from 1.40 mg/dl (quartiles: 1.20, 1.75 mg/dl) at baseline to 1.30 mg/dl (quartiles: 1.1, 1.55 mg/dl) at 6 months (p=0.17). Significant multivariate independent predictors of decreased creatinine included higher baseline serum creatinine levels (adjusted OR per quartile increment, 2.5 [1.3 to 4.7], p=0.004) and lower C-reactive protein levels (adjusted OR per quartile increment 0.39 [0.19 to 0.82], p=0.013). CONCLUSIONS: Patients with higher serum creatinine and lower CRP derive the most benefit from renal artery stenting.

EuroSCORE predicts long-term mortality of unselected patients undergoing percutaneous coronary interventions.

BACKGROUND: The European System for Cardiac Operative Risk Evaluation (EuroSCORE) is a simple risk model able to predict early and late mortality after cardiac surgery. Recent data suggest that this score may also predict early clinical outcome after percutaneous coronary intervention (PCI). Data regarding EuroSCORE usefulness to predict late outcome after PCI in unselected patients are lacking. METHODS: EuroSCORE was prospectively assessed in consecutive patients undergoing PCI during 18 months. The primary end-point was cardiac mortality during the follow-up after PCI. Total mortality was the secondary end-point. Kaplan-Meyer analyses were performed dividing the study population in three subgroups according to the additive EuroSCORE algorithm (low risk group: EuroSCORE 0-2; medium risk group: EuroSCORE 3-5; high-risk group: EuroSCORE ≥ 6). Receiver operating characteristics (ROC) curve and landmark analysis on cardiac mortality after 30 days were performed. RESULTS: The study population comprised 1170 patients undergoing PCI. Mean follow-up duration was 633 days (range: 365-1000 days). Cardiac mortality was 2%; 2.4%; 13.2% in patients with low, medium and high EuroSCORE respectively. Kaplan-Meyer survival curves for cardiac death differed significantly between EuroSCORE groups (p<0.0001). The area under the ROC curve for the prediction of cardiac death was 0.77. Similar results were obtained for total mortality. At landmark analysis starting 30 days after PCI, EuroSCORE groups were significantly associated with different survival in the long term (P=0.014). CONCLUSION: EuroSCORE risk model can be efficiently utilized to predict late mortality in consecutive, unselected, patients undergoing PCI.

Angiographic and clinical outcome of percutaneous coronary intervention for in-stent restenosis of bifurcated lesions.

AIMS: Restenosis and bifurcated lesions represent technically challenging lesions for percutaneous coronary interventions (PCI). Data regarding procedural and clinical outcome of re-PCI for restenosis of stented bifurcated lesions are lacking. Our aims were to evaluate angiographic and procedural results and one-year clinical outcome of PCI for restenosis of stented bifurcated lesions. METHODS AND RESULTS: Consecutive patients undergoing PCI for restenosis of one bifurcated lesion previously treated by stent implantation at our centre entered the study. The primary endpoint was angiographic and procedural success, defined as final residual stenosis ≤30% in the main vessel with TIMI 3 flow in both MV and side branch, and stenosis ≤50% in the SB without death, myocardial infarction or target vessel revascularisation during hospitalisation. The secondary endpoint was the incidence of major adverse cardiac events at one-year clinical follow-up. The study population included 64 patients treated by PCI on a single restenotic bifurcated lesion. Angiographic and procedural success was achieved in 61 cases (95.3%) whereas the three cases of failure were due to SB residual stenosis >50%. At one year, MACE rate was 18.7% (12/64) with rates of cardiac death, MI and TVR of 1.6% (1/64), 6.2% (4/64) and 18.7% (12/64), respectively. No cases of stent thrombosis occurred. Patients treated by a single drug-eluting stent (DES) on main vessel (MV) had a significant lower rate of MACE at one year as compared to patients treated with balloon only PCI or by double-stenting technique or with a BMS, irrespective of the strategy adopted: 4/37 (10.8%) vs. 8/27 (29.6%); p=0.04. CONCLUSIONS: PCI in restenotic bifurcated lesions can be a good treatment option with high rates of angiographic and procedural success and an acceptable rate of long-term MACE. The use of a single DES implantation may be a promising strategy as it is associated with lower rates of MACE in the long term.

INtimal hyPerplasia evAluated by oCT in de novo COROnary lesions treated by drug-eluting balloon and bare-metal stent (IN-PACT CORO): study protocol for a randomized controlled trial.

BACKGROUND: Neointimal hyperplasia plays a pivotal role in the pathogenesis of in-stent restenosis in patients undergoing percutaneous coronary interventions. Drug-eluting balloons are a promising tool to prevent restenosis after coronary angioplasty. Moreover, an increased knowledge of the pathophysiology of restenosis my help improve therapeutic strategies. METHODS/DESIGN: We present the design of an open-label, randomized three-arm clinical trial aimed to assess whether a strategy of bare-metal stent implantation with additional use of drug-eluting balloons, either before (pre-dilation) or after stenting (post-dilation), reduces the primary endpoint of in-stent neointimal hyperplasia area as compared with a strategy of bare-metal stent implantation alone. This primary endpoint will be assessed by optical coherence tomography at follow-up. Secondary endpoints will be the percentage of uncovered struts, and the percentage of struts with incomplete apposition. An ancillary study investigating the relation between systemic levels of endothelial progenitors cells and neointimal hyperplasia, and the interaction between endothelial progenitors cell levels and drug-eluting balloons has been planned. Thirty consecutive patients undergoing percutaneous coronary intervention will be randomized with a 1:1:1 design to bare-metal stent implantation alone (n = 10); bare-metal stent implantation after pre-dilation with a drug-eluting balloon (n = 10); or bare-metal stent implantation followed by post-dilation with a drug-eluting balloon (n = 10). Six-month follow-up coronary angiography with optical coherence tomography imaging of the stented segment will be performed in all patients. Blood samples for the assessment of endothelial progenitors cell levels will be collected on admission and at 6 months. DISCUSSION: Experimental and early clinical data showed that inhibition of neointimal hyperplasia may be obtained by local administration of antiproliferative drugs loaded on the surface of angioplasty balloons. The INtimal hyPerplasia evAluated by oCT in de novo COROnary lesions treated by drug-eluting balloon and bare-metal stent (IN-PACT CORO) trial was conceived to test the superiority of a strategy of bare-metal stent implantation with additional drug-eluting balloon use (either before or after stenting) versus a strategy of bare-metal stent implantation alone for the reduction of neointimal hyperplasia. We also planned an ancillary study to assess the role of endothelial progenitors cells in the pathophysiology of neointimal hyperplasia. TRIAL REGISTRATION: Clinicaltrials.gov NCT01057563.

Impact of radial-to-aorta vascular anatomical variants on risk of failure in trans-radial coronary procedures.

OBJECTIVES: To assess the impact of an "operative" classification of vascular anatomic variants on the feasibility of trans-radial approach. BACKGROUND: Vascular anatomic variants located from the wrist to the aorta may influence the feasibility of trans-radial procedures. Recently, a new "operative" classification of these variants was proposed. METHODS: Consecutive trans-radial diagnostic or interventional catheterizations were considered. Vascular anatomic variants were classified according to 10 categories and sub-grouped according to the ABC classification (A: radial-brachial arterial axis; B: axillary-subclavian-anonymous axis; C: aortic arch). Primary study end-point was failure of trans-radial approach (necessity to cross-over to another approach to complete the procedure). RESULTS: Three thousand four hundred seventy-seven consecutive radial procedures were considered. Anatomic variants were diagnosed in 308 procedures (8.8%): A variants: 7.2%, B variants: 1.9%; C variants: 0.3%. Failure occurred in 2.0% of procedures. Failure rate was 0.7% in the absence of variants vs.15.2% in the presence of any variant (P < 0.0001, OR 27.7, 95%CI 16.3-46.9). Each of the 10 variants was significantly associated with increased failure rate. Each of the three level-subgroups of variants was significantly associated to the risk of failure (failure 14.7% in A level, 13.9% in B level, 33.3% in C level; P < 0.0001 vs. absence of variants). CONCLUSIONS: Failure of trans-radial procedures is associated to anatomic variants located from the wrist to the aorta. The "operative" ABC classification of anatomic variants is useful not only to categorize these anatomic variants, but also to predict the risk of failure of trans-radial approach.

Vascular complications and access crossover in 10,676 transradial percutaneous coronary procedures.

BACKGROUND: Randomized trials have shown that transradial approach, compared with transfemoral, reduces vascular complications (VCs) of coronary procedures in selected patients. Yet, radial approach is associated to a variety of access-site VC as well as to a higher failure rate compared with femoral access. METHODS: At our institution, from May 2005 to May 2010, we prospectively assessed the occurrence and outcome of VC in consecutive patients undergoing transradial percutaneous coronary procedures performed by trained radial operators. The need of access crossover to complete the procedure was also prospectively investigated. Vascular complications were classified as "radial related" or "nonradial related" (in the case of access crossover). Vascular complications were also classified "major" if requiring surgery and/or blood transfusions or causing hemoglobin drop >3 g/dL. RESULTS: Ten thousand six hundred seventy-six procedures were performed using a right radial (87.5%), left radial (12.4%), or ulnar (0.1%) artery as primary access. A total of 53 VCs (0.5%) were observed: 44 (83%) radial related and 9 (17%) nonradial related. Major VCs occurred in 16 patients only (0.2%) and were radial related in 10 (62.5%) and nonradial related in 6 (37.5%) patients. Vascular complications rate was stable during the study and independent of operator's experience. Access crossover rate was 4.9%, differed according to the operator radial experience and significantly decreased over time. CONCLUSIONS: The present study, conducted in a center with high volume of radial procedures, shows that transradial approach is associated with a very low rate of VC, which is stable over time. On the contrary, access crossover rate decreased over time and differed according to operator (radial) experience.