Right Ventricular Hypertrophy, Systolic Function, and Disease Severity in Anderson-Fabry Disease: An Echocardiographic Study.

BACKGROUND: Right ventricular (RV) involvement has been described in Anderson-Fabry disease (AFD), especially in patients with established Fabry cardiomyopathy (FC). However, few and controversial data on RV systolic function are available, and there are no specific tissue Doppler studies. METHODS: Detailed echocardiographic examinations were performed in 45 patients with AFD. FC, defined as maximal left ventricular wall thickness ≥ 15 mm, was present in 12. The Mainz Severity Score Index was calculated for each patient. Pulsed tissue Doppler was applied to the RV free wall at the tricuspid annular level and at the septal and lateral corners at the mitral annular level to obtain systolic tissue Doppler velocities (RV Sa, septal Sa, and lateral Sa, respectively). Twelve patients with amyloid light-chain cardiac amyloidosis were studied as a control group. RESULTS: Echocardiography revealed RV hypertrophy (RVH) in 31% of patients with AFD, all but one of whom were male and all of whom had concomitant left ventricular hypertrophy (LVH). All patients with AFD had normal RV fractional area change (47.9 ± 6.5%) and tricuspid annular plane systolic excursion (21.7 ± 3.2 mm) and all but one also had normal RV Sa (13.2 ± 2.2 cm/sec). RVH positively correlated with indices of LVH (r = 0.8, P = .0001, for all parameters evaluated), as well as with Mainz Severity Score Index (r = 0.70, P = .0001). Septal and lateral Sa were decreased in almost all patients (means, 7.7 ± 1.8 and 7.9 ± 1.9 cm/sec, respectively), irrespective of the presence of LVH. Compared with control subjects with cardiac amyloidosis, patients with FC showed better indices of RV systolic function (P < .001 for all: tricuspid annular plane systolic excursion, RV fractional area change, and RV Sa) despite similar RV wall thickness (6.2 ± 1.2 vs 6.9 ± 1.9 mm, P = NS). CONCLUSIONS: RVH is common in patients with AFD and correlates with disease severity and LVH. RVH, however, does not significantly affect RV systolic function. Patients with FC have better RV systolic function compared with those with cardiac amyloidosis with similar levels of RV thickness. The combination of low LV Sa values and normal RV Sa values might be helpful in the differential diagnosis of infiltrative heart disease.

Comparison of Right and Left Upper Limb Arterial Variants in Patients Undergoing Bilateral Transradial Procedures.

BACKGROUND: Transradial approach (TRA), when compared with transfemoral, improves the safety of percutaneous coronary procedures. Arterial axis variants are known to hinder the performance of transradial approach percutaneous coronary procedures. Data on the occurrence of arterial axis variants in the right and left arm arterial axes of individual patients are lacking. METHODS AND RESULTS: From a single-center prospective registry, we selected all patients in whom bilateral upper limb arterial anatomy was assessed based on the performance of left and right radial catheterization obtained during the same or during repeat coronary diagnostic or interventional procedure(s). The occurrence of upper right and left limb arterial axis variants was classified according to the previously described operative ABC classification. A total of 610 patients were identified. An ABC upper limb arterial axis variant was detected in 156 (25.6%) patients. Variants were right-sided only in 65 (11.0%), left-sided only in 40 (6.6%), and bilateral in 46 (7.5%) patients. Thus, arterial axis variants were significantly more common in the right side (P=0.02). Bilateral arterial variants were significantly associated with age, female sex, and valvulopathy. Both A (radial/brachial) and B (axillary/subclavian/innominate) variants exhibited concordance across the 2 sides (odds ratio, 7.2; 95% confidence interval, 4.1-12.7 and 8.0; 95% confidence interval, 2.1-30.9, respectively). CONCLUSIONS: The occurrence of an anatomic variant potentially hindering transradial approach coronary diagnostic or interventional procedures is bilateral in <8% of cases and is more common in the right arm. Such information may guide, during the clinical practice, the access selection in the case of repeat procedures or need for additional accesses.

Results of emergency postoperative re-angiography after cardiac surgery procedures.

BACKGROUND: The purpose of this study was to evaluate the diagnostic and therapeutic role of emergency coronary angiography (ECA) in the setting of acute ischemic or hemodynamic instability after cardiac surgery. METHODS: Between January 2005 and September 2014 we prospectively collected data from a consecutive cohort of 5,275 patients who underwent cardiac surgery. Patients who underwent ECA due to new ST-segment changes on electrocardiogram (ECG), ventricular arrhythmias, cardiac arrest or hemodynamic collapse, new changes in regional wall motion, or any other relevant suspect of myocardial ischemia during postoperative intensive care unit stay were included. RESULTS: Forty patients (0.7% of the overall population) were enrolled. Nineteen patients (47.5%) received isolated coronary surgery, 21 (52.5%) underwent valve or aortic or combined operations. The most common indications to ECA were new ECG or echo signs of acute ischemia (62.5%). The mean time from primary operation to ECA was 51 hours (27 minutes to 9 days). Graft failure was found in 17 cases (42.5%), native coronary artery occlusion in 7 (20%), and coronary spasm in 5 (12.5%). No pathologic alterations were found in 7 cases (17.5%). Three patients (7.5%) underwent reoperation (group 1), 15 (37.5%) underwent percutaneous interventions (PCI) (group 2), and 22 (55%) were managed conservatively (group 3). In-hospital mortality was 100% in group 1, 6% in group 2, and 0% in group 3; 93% of the patients who underwent PCI had complete resolution of the ischemic or hemodynamic problems. No complications related to angiography occurred. Kaplan-Meier survival curves differed significantly according to the post-angiography management. At multivariate analysis combined surgery and the strategy of treatment were independent predictors of long-term mortality. CONCLUSIONS: Emergency coronary angiography is safe and allows diagnosis and resolution of the instability in the great majority of cases. An ECA should be the first-line measure in case of acute ischemic or hemodynamic instability after cardiac surgery.

Usefulness of EuroSCORE systems for risk stratification.

Risk stratification of patients undergoing open-heart surgery or percutaneous interventions may help physicians select the best individual management of patients with advanced heart disease.European System for Cardiac Operative Risk Evaluation (EuroSCORE) is an easy-to-calculate, clinical scoring system which has been developed for coronary surgery and applied in various cardiological settings. Recently, the EuroSCORE II model has been launched with the aim of improving the stratification performance over the first model.In the present study, we review the available scientific data on the use of EuroSCORE systems in patients undergoing surgical or percutaneous procedures.

Seguimiento de 3 años de pacientes con lesiones de bifurcación tratados con stents liberadores de sirolimus o everolimus: estudio de colaboración de SEAside y CORpal / Three-year Follow-up of Patients With Bifurcation Lesions Treated With Sirolimus- or Everolimus-eluting Stents: SEAside and CORpal Cooperative Study

Introducción y objetivos: Comparar la incidencia en 3 años de eventos mayores en pacientes con lesiones de bifurcación tratados con implante condicional de stents liberadores de sirolimus frente astents liberadores de everolimus. Métodos: Se llevó a cabo un análisis combinado de dos ensayos prospectivos y aleatorizados de metodología similar (SEAside y CORpal). En dichos ensayos, se asignó aleatoriamente a 443 pacientes con lesiones de bifurcación a tratamiento con stents liberadores de sirolimus o everolimus. El seguimiento clínico se amplió a 3 años para evaluar los eventos adversos cardiovasculares mayores (muerte o infarto agudo de miocardio o revascularización de vaso diana). Resultados: A los 3 años, la supervivencia libre de eventos adversos cardiovasculares mayores fue del 93,2 y el 91,3% en los grupos de stents liberadores de everolimus y sirolimus respectivamente (p = 0,16). El análisis exploratorio de referencia para los eventos tardíos (aparecidos después de los primeros 12 meses) mostró una frecuencia de eventos adversos cardiovasculares mayores significativamente inferior en el grupo de stents liberadores de everolimus: el 1,4 frente al 5,4% en el grupo de stents liberadores de sirolimus (p = 0,02). Conclusiones: El implante de stents liberadores de sirolimus o everolimus en lesiones de bifurcación se asocia a unas tasas bajas de eventos adversos mayores a los 3 años de seguimiento. Los resultados de un subanálisis de los eventos que se produjeron después del primer año indican una tasa de eventos con los stents liberadores de everolimus inferior que con los liberadores de sirolimus, lo cual indica que está justificado realizar estudios exploratorios del beneficio clínico a largo plazo obtenido con los stents liberadores de fármacos de última generación (AU)

Introduction and objectives: To compare the 3-year incidence of major events in patients with bifurcation lesions treated with provisional sirolimus-eluting stents vs everolimus-eluting stents. Methods: A pooled analysis of 2 prospective randomized trials with similar methodology (SEAside and CORpal) was performed. In these trials, 443 patients with bifurcation lesions were randomly assigned to treatment with either sirolimus-eluting stents or everolimus-eluting stents. The clinical follow-up was extended up to 3 years to assess major adverse cardiovascular events (death or acute myocardial infarction or target vessel revascularization). Results: At 3 years, survival free of major adverse cardiovascular events was 93.2% vs 91.3% in the everolimus-eluting stent group vs the sirolimus-eluting stent group (P = .16). Exploratory land-mark analysis for late events (occurring after 12 months) showed significantly fewer major adverse cardiovascular events in the everolimus-eluting stent group: 1.4% vs 5.4% in the sirolimus-eluting stent group (P = .02). Conclusions: Provisional stenting with either sirolimus-eluting stents or everolimus-eluting stents in bifurcation lesions is associated with low rates of major adverse events at 3-years' follow-up. The results of a subanalysis of events beyond 1 year, showing a lower event rate with everolimus-eluting stents than with sirolimus-eluting stents, suggest that studies exploring the long-term clinical benefit of the latest generation of drug-eluting stents are warranted (AU)

Three-year follow-up of patients with bifurcation lesions treated with sirolimus- or everolimus-eluting stents: SEAside and CORpal cooperative study.

INTRODUCTION AND OBJECTIVES: To compare the 3-year incidence of major events in patients with bifurcation lesions treated with provisional sirolimus-eluting stents vs everolimus-eluting stents. METHODS: A pooled analysis of 2 prospective randomized trials with similar methodology (SEAside and CORpal) was performed. In these trials, 443 patients with bifurcation lesions were randomly assigned to treatment with either sirolimus-eluting stents or everolimus-eluting stents. The clinical follow-up was extended up to 3 years to assess major adverse cardiovascular events (death or acute myocardial infarction or target vessel revascularization). RESULTS: At 3 years, survival free of major adverse cardiovascular events was 93.2% vs 91.3% in the everolimus-eluting stent group vs the sirolimus-eluting stent group (P = .16). Exploratory land-mark analysis for late events (occurring after 12 months) showed significantly fewer major adverse cardiovascular events in the everolimus-eluting stent group: 1.4% vs 5.4% in the sirolimus-eluting stent group (P = .02). CONCLUSIONS: Provisional stenting with either sirolimus-eluting stents or everolimus-eluting stents in bifurcation lesions is associated with low rates of major adverse events at 3-years' follow-up. The results of a subanalysis of events beyond 1 year, showing a lower event rate with everolimus-eluting stents than with sirolimus-eluting stents, suggest that studies exploring the long-term clinical benefit of the latest generation of drug-eluting stents are warranted.

Fractional flow reserve or optical coherence tomography guidance to revascularize intermediate coronary stenosis using angioplasty (FORZA) trial: study protocol for a randomized controlled trial.

BACKGROUND: The management of patients with angiographically intermediate coronary lesions is a major clinical issue. Fractional flow reserve provides validated functional insights while optical coherence tomography provides high resolution anatomic imaging. Both techniques may be applied to guide management in case of angiographically intermediate coronary lesions. Moreover, these techniques may be used to optimize the result of percutaneous coronary intervention. We aim to compare the clinical and economic impact of fractional flow reserve versus optical coherence tomography guidance in patients with angiographically intermediate coronary lesions. METHODS/DESIGN: Patients with at least one angiographically intermediate coronary lesion will be randomized (ratio 1:1) to fractional flow reserve or optical coherence tomography guidance. In the fractional flow reserve arm, percutaneous coronary intervention will be performed if fractional flow reserve value is ≤0.80, and will be conducted with the aim of achieving a post-percutaneous coronary intervention fractional flow reserve target value of ≥0.90. In the optical coherence tomography arm, percutaneous coronary intervention will be performed if percentage of area stenosis (AS%) is ≥75% or 50 to 75% with minimal lumen area <2.5 mm2, or if a major plaque ulceration is detected. In case of percutaneous coronary intervention, optical coherence tomography will guide the procedure in order to minimize under-expansion, malapposition, and edge dissections.Cost load and clinical outcome will be prospectively assessed at one and thirteen months. The assessed clinical outcome measures will be: major cardiovascular events and occurrence of significant angina defined as a Seattle Angina Questionnaire score <90 in the angina frequency scale. DISCUSSION: The FORZA trial will provide useful guidance for the management of patients with coronary artery disease by prospectively assessing the use of two techniques representing the gold standard for functional and anatomical definition of coronary plaques. TRIAL REGISTRATION: Clinicaltrials.gov NCT01824030.

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.

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.

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.

Management of the access site after transradial percutaneous procedures: literature overview.

The transradial approach (TRA) is emerging as a promising strategy to improve the safety of percutaneous coronary diagnostic or interventional procedures. Nevertheless, a series of specific complications related to the radial access have been described so that their prevention and optimal management is clinically relevant. In this article, the types of access-related vascular complications potentially occurring after TRA and their possible management are described. In particular, the vascular complications have been classified in three groups according to the main pathogenetic mechanism: thrombotic, hemorrhagic and nonthrombotic nonhemorrhagic. Moreover, a practical operative protocol for prompt diagnosis and treatment has been proposed.

The occurrence of radial artery occlusion following catheterization.

Radial artery occlusion (RAO) is a usually silent complication of transradial approach that may prevent future transradial procedures. It is caused by intimal hyperplasia, intima-media thickening and luminal thrombosis. RAO incidence has been reported with a wide range, probably due to different catheterization protocols and diagnosis tests adopted. Since simple pulse check at the level of radial cannulation is not reliable, plethysmography and duplex ultrasound are required to assure diagnosis. Besides the relevance of other clinical and procedural factors, inadequate heparinization and occlusive hemostasis constitute the main modifiable factors associated with risk of RAO. Finally, RAO should not be regarded as an irreversible condition since ulnar artery compression may restore patency in the case of early diagnosis, and recanalization techniques have been recently proposed to allow successful recatheterization in RAO patients.

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.

Intracoronary use of GP IIb/IIIa inhibitors in percutaneous coronary interventions.

The glycoprotein (GP) IIb/IIIa receptor is critical to the process of platelet aggregation and thrombus formation as it serves as the final common pathway for platelet aggregation. For this reason, the development of GP IIb/IIIa inhibitors that block fibrinogen binding to the receptor has become an attractive strategy for antiplatelet therapy with an expected strong and specific effect. Presently, there are three commercially available GP IIb/IIIa inhibitors: abciximab, eptifibatide and tirofiban. All three drugs are commonly administered intravenously, and large-scale clinical trials have demonstrated a clear clinical benefit and good safety profile in patients at high risk, especially those undergoing percutaneous coronary interventions (PCI). Recently, several studies tested the intracoronary (IC) route for GP IIb/IIIa inhibitors in order to verify its safety and its possible superiority as compared to the intravenous (IV) route. The majority of the studies testing the IC route were conducted using abciximab and in patients with STEMI with better results in terms of myocardial reperfusion and infarct size and also promising results in terms of clinical outcome. On the IC administration of eptifibatide and tirofiban only some, even if promising, data are available. Larger and randomized studies are warranted to confirm the superiority of the IC route of administration of the GP IIb/IIIa inhibitors to the IV one in patients with coronary artery disease undergoing PCI.

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.

Feasibility of complex coronary and peripheral interventions by trans-radial approach using large sheaths.

BACKGROUND: Trans-radial approach (TRA) reduces vascular access-site complications but has some technical limitations. Usually, TRA procedures are performed using 5 Fr or 6 Fr sheaths, whereas complex interventions requiring larger sheaths are approached by trans-femoral access. METHODS: During 4 years, at two Institutions with high TRA use, we have attempted to perform selected complex coronary or peripheral interventions by TRA using sheaths larger than 6 Fr. Clinical and procedural data were prospectively collected. Attempt to place a 7 Fr or 8 Fr sheath (according to the planned strategy of the procedure) was performed after 5-6 Fr sheath insertion, administration of intra-arterial nitrates and radial artery angiography. Late (>3 months) patency of the radial artery was checked (by angiography in the case of repeated procedures or by palpation + reverse Allen test). RESULTS: We collected 60 patients in which TRA large sheath insertion was attempted. The large sheath (87% 7 Fr, 13% 8 Fr) was successfully placed in all cases. Most of the procedures were complex coronary interventions (bifurcated or highly thrombotic or calcific chronic total occlusive lesions), whereas 8.3% were carotid interventions. Procedural success rate was 98.3% (1 failure to reopen a chronic total occlusion). No access-site related complication occurred. In 57 (95%) patients, late radial artery patency was assessed and showed patency in 90% of the cases, the remaining patients having asymptomatic collateralized occlusion. CONCLUSIONS: In selected patients, complex percutaneous interventions requiring 7-8 Fr sheaths can be successfully performed by RA approach without access-site clinical consequences.

Comparative assessment of mammalian target of rapamycin inhibitor-eluting stents in the treatment of coronary artery bifurcation lesions: the CASTOR-Bifurcation registry.

Drug-eluting stents (DES) have revolutionized the treatment of coronary bifurcation lesions. Among different DES types, sirolimus-eluting stents (SES) showed better outcomes than paclitaxel-eluting stents. Because novel sirolimus analogues have been implemented in DES, a prospective observational comparison was undertaken to compare major mammalian target of rapamycin inhibitor-eluting stents in the treatment of bifurcation lesions according to the provisional T-stenting and small protrusion (TAP) technique. Overall, 187 patients (165 men, 65 ± 10 years) were enrolled in the study: 80 patients received a SES, whereas zotarolimus-eluting stents (ZES) were implanted in 53 patients and everolimus-eluting stents (EvES) in 62 patients. Primary end-point of the study was the 12-month incidence of target bifurcation failure (TBF) defined as occurrence of cardiovascular death, nonfatal myocardial infarction (MI), and target vessel revascularization (TVR) or angiographic documentation of > 50% restenosis on the main vessel or TIMI flow < 3 on the side branch. Groups were homogeneous according to main clinical and angiographic characteristics. Overall, 17 (9.1%) patients had TBF: 4 (2.1%) patients had nonfatal non-ST-segment elevation MI, 9 (4.8%) patients underwent TVR, and 6 (3.2%) patients had an angiographic restenosis. The rate of TBF was statistically different among the three groups (7.9% in SES group, 18% in ZES group, and 3.3% in EvES group, P = 0.024). Previous MI was associated with a worse outcome (P = 0.025), whereas final kissing balloon was associated with a better outcome (P = 0.045). In conclusion, in this prospective registry, significant differences between DES were found in the outcome of patients treated for coronary bifurcation lesions according to provisional TAP technique. Thus, prospective randomized trials in this field are needed.