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Drug-eluting stents (DESs) with controlled antiproliferative drug release reduce restenosis risk, but durable polymers can delay healing and inhibit reendothelialization. The Firehawk biodegradable polymer sirolimus-eluting stent (BP-SES) has a fully biodegradable sirolimus-containing polymer coating localized to recessed abluminal grooves on the stent surface and delivers roughly one-third the drug dose of other DESs. We report the primary results of the TARGET-IV NA (Firehawk Rapamycin Target Eluting Coronary Stent North American Trial) randomized controlled trial comparing clinical outcomes with BP-SES vs currently used second-generation DESs. The TARGET-IV NA study was a prospective, multicenter, single-blind, 1:1 randomized noninferiority trial comparing the BP-SES with control in North America and Europe among patients undergoing percutaneous coronary intervention for chronic or acute coronary syndromes. The primary endpoint was target lesion failure (TLF) at 12 months (composite of cardiac death, target vessel–related myocardial infarction, or ischemia-driven target lesion revascularization). The primary analysis (intention-to-treat) tested noninferiority of BP-SES vs control using an absolute margin of 3.85% and 1-sided α of 0.025. Noninferiority-powered secondary endpoints were tested in an optical coherence tomography substudy (endpoint: mean neointimal hyperplasia thickness) and an angiography substudy (endpoint: in-stent late lumen loss). A total of 1,720 patients (mean age 66 years; 74% male) with 2,159 lesions were randomly allocated to receive either BP-SES (860 patients, 1,057 lesions) or control second-generation DES (860 patients, 1,084 lesions). A total of 61% of patients presented with stable coronary disease, 32% had unstable angina, and 7% had non-ST-segment elevation myocardial infarction (NSTEMI) or recent ST-segment elevation myocardial infarction. The rate of TLF with BP-SES was noninferior to control at 12 months (3.4% vs 3.3%, absolute risk difference 0.13%, upper bound 97.5% CI: 2.03, P noninferiority < 0.0001). Cardiac death, myocardial infarction, and stent thrombosis rates were similar between groups. Angiographic follow-up was available in 104 patients (97.2% of those enrolled in the angiographic substudy) and 128 (94.1%) lesions. At 13 months, the powered secondary endpoint of mean in-stent late lumen loss was 0.149 ± 0.263 mm for BP-SES and 0.327 ± 0.463 mm for control (least squares mean difference: −0.178; 90% CI: −0.2943 to −0.0632; P noninferiority < 0.0001). The optical coherence tomography substudy included 37 patients (42 lesions) with no difference in mean neointimal hyperplasia thickness between groups at 13 months (P noninferiority = 0.01). The biodegradable polymer sirolimus-eluting stent was noninferior to currently used second-generation DES with regard to TLF at 1 year. (Firehawk® Rapamycin Target Eluting Coronary Stent North American Trial; NCT04562532) [Display omitted] [ABSTRACT FROM AUTHOR]

Emerging evidence from randomized clinical trials (RCTs) comparing distal radial access (DRA) with conventional radial access (RA) is available. The aim of this study was to provide a quantitative appraisal of the effects of DRA) vs conventional RA for coronary angiography with or without intervention. The PubMed, Embase, Cochrane Central Register of Controlled Trials, and ClinicalTrials.gov databases were searched for RCT comparing DRA vs conventional RA for coronary angiography and/or intervention. Data were pooled by meta-analysis using a random-effects model. The primary endpoint was radial artery occlusion (RAO) at the longest available follow-up. Fourteen studies enrolling 6,208 participants were included. Compared with conventional RA, DRA was associated with a significant lower risk of RAO, either detected at latest follow-up (risk ratio [RR]: 0.36; 95% CI: 0.23-0.56; P < 0.001; number needed to treat [NNT] = 30) or in-hospital (RR: 0.32; 95% CI: 0.19-0.53; P < 0.001; NNT = 28), as well as EASY (Early Discharge After Transradial Stenting of Coronary Arteries) ≥II hematoma (RR: 0.51; 95% CI: 0.27-0.96; P = 0.04; NNT = 107). By contrast, DRA was associated with a higher risk of access site crossover (RR: 3.08; 95% CI: 1.88-5.06; P < 0.001; NNT = 12), a longer time for radial puncture (standardized mean difference [SMD]: 3.56; 95% CI: 0.96-6.16; P < 0.001), a longer time for sheath insertion (SMD: 0.37; 95% CI: 0.16-0.58; P < 0.001), and a higher number of puncture attempts (SMD: 0.59, 95% CI: 0.48-0.69; P < 0.001). Compared with conventional RA, DRA is associated with lower risks of RAO and EASY ≥II hematoma but requires longer time for radial artery cannulation and sheath insertion, more puncture attempts, and a higher access site crossover. [Display omitted] [ABSTRACT FROM AUTHOR]

[Display omitted] [ABSTRACT FROM AUTHOR]

An 80-year-old man followed for aortic stenosis was found to have an intracardiac mass. Multiple imaging modalities were inconclusive in characterizing the mass but raised concerns about the potential malignancy of the mass. Fear of operating on an elderly patient with a potential for cardiac neoplasia led to a percutaneous transseptal biopsy that failed to provide a clear diagnosis. Cardiac valvular surgery was performed in addition to excisional biopsy of the mass that turned out to be caseous necrosis of mitral annular calcifications. [ABSTRACT FROM AUTHOR]

Biodegradable stents show promise to revolutionize coronary artery disease treatment. Its successful implementation in the global market remains limited due to the constraints of current generation biodegradable materials. Cold gas dynamic spraying (CGDS) has been proposed as a manufacturing approach to fabricate a metallic biodegradable amalgamate for stent application. Iron and 316L stainless steel powders are combined in a 4:1 ratio to create a novel biomaterial through cold spray. Cold spray processing however, produces a coating in a work hardened state, with limited ductility, which is a critical mechanical property in stent design. To this end, the influence of annealing temperature on the mechanical and corrosion performances of the proposed Fe-316L amalgamate is investigated. It was found that annealing at 1300 °C yielded a complex material microstructure, with an ultimate tensile strength of approximately 280 MPa and ductility of 23%. The static corrosion rate determined at this annealing temperature was equal to 0.22 mg cm−2 day−1, with multiple corrosion species identified within the degradation layers. Precipitates were observed throughout the microstructure, which appeared to accelerate the overall corrosion behaviour. It was shown that cold-sprayed Fe-316L has significant potential to be implemented in a clinical setting. Biodegradable stents have potential to significantly improve treatment of coronary artery disease by decreasing or potentially eliminating late-term complications, including stent fracture and in-stent restenosis. Current generation polymer biodegradable stents have led to poorer patient outcomes in comparison to drug-eluting stents, however, and it is evident that metallic biomaterials are required, which have increased strength. To this end, a novel iron and stainless steel 316L biomaterial is proposed, fabricated through cold-gas dynamic spraying. This study analyses the effect of annealing on the Fe-316L biomaterial through corrosion, mechanical, and microstructural investigations. The quantitative data presented in this work suggests that Fe-316L, in its annealed condition, has the mechanical and corrosion properties necessary for biodegradable stent application. [ABSTRACT FROM AUTHOR]

Objectives The authors sought to determine the relationships between left radial access (LRA) or right radial access (RRA) and clinical outcomes using the British Cardiovascular Intervention Society (BCIS) database. Background LRA has been shown to offer procedural advantages over RRA in percutaneous coronary intervention (PCI) although few data exist from a national perspective around its use and association with clinical outcomes. Methods The authors investigated the relationship between use of LRA or RRA and clinical outcomes of in-hospital or 30-day mortality, major adverse cardiovascular events (MACE), in-hospital stroke, and major bleeding complications in patients undergoing PCI between 2007 and 2014. Results Of 342,806 cases identified, 328,495 (96%) were RRA and 14,311 (4%) were LRA. Use of LRA increased from 3.2% to 4.6% from 2007 to 2014. In patients undergoing a repeat PCI procedure, the use of RRA dropped to 72% at the second procedure and was even lower in females (65%) and patients >75 years of age (70%). Use of LRA (compared with RRA) was not associated with significant differences in in-hospital mortality (odds ratio [OR]: 1.19, 95% confidence interval [CI]: 0.90 to 1.57; p = 0.20), 30-day mortality (OR: 1.17, 95% CI: 0.93 to 1.74; p = 0.16), MACE (OR: 1.06, 95% CI: 0.86 to 1.32; p = 0.56), or major bleeding (OR: 1.22, 95% CI: 0.87 to 1.77; p = 0.24). In propensity match analysis, LRA was associated with a significant decrease in in-hospital stroke (OR: 0.52, 95% CI: 0.37 to 0.82; p = 0.005). Conclusions In this large PCI database, use of LRA is limited compared with RRA but conveys no increased risk of adverse outcomes, but may be associated with a reduction in PCI-related stroke complications. [ABSTRACT FROM AUTHOR]

Background: Fractional flow reserve (FFR) prior to percutaneous coronary intervention (PCI) is useful to guide treatment. Whether post-PCI FFR assessment might have clinical impact is controversial. The aim of this study is to evaluate the range of post-PCI FFR values and analyze the relationship between post-PCI FFR and clinical outcomes.Methods: We systematically searched the PubMed, EMBASE, and Cochrane Library databases with cross-referencing of articles reporting post-PCI FFR and correlating post-PCI FFR values and clinical outcomes. The outcomes of interest were the immediate post-PCI FFR values and the correlations between post-PCI FFR and the incidence of repeat intervention and major adverse cardiac events (MACE).Results: From 1995 to 2015, a total of 105 studies (n = 7470) were included, with 46 studies reporting post-PCI FFR and 59 studies evaluating relationship between post-PCI and clinical outcomes up to 30 months after PCI. Overall, post-PCI FFR values demonstrated a normal distribution with a mean value of 0.90 ± 0.04. There was a positive correlation between the percentage of stent use and post-PCI FFR (P < .0001). Meta-regression analysis indicated that higher post-PCI FFR values were associated with reduced rates of repeat intervention (P < .0001) and MACE (P = .0013). A post-PCI FFR ≥0.90 was associated with significantly lower risk of repeat PCI (odds ratio 0.43, 95% CI 0.34-0.56, P < .0001) and MACE (odds ratio 0.71, 95% CI 0.59-0.85, P = .0003).Conclusions: FFR measurement after PCI was associated with prognostic significance. Further investigation is required to assess the role of post-PCI FFR and validate cutoff values in contemporary clinical practice. [ABSTRACT FROM AUTHOR]

Background: Stroke is a rare but potentially catastrophic complication of cardiac catheterization. Although some procedural aspects are known to influence stroke risk, the impact of radial versus femoral access site use is unclear. Early observational studies and limited randomized trial data suggested more frequent embolic events with radial access. Subsequently, larger pooled analyses have shown no clear differences in stroke risk but were limited by low event rates. Recent publication of relevant new data prompted our reevaluation of this concern. Therefore, we conducted a systematic review and meta-analysis to evaluate stroke complicating cardiac catheterization with use of transradial versus transfemoral access.Methods and Results: A search of MEDLINE and EMBASE was undertaken using OVID SP with appropriate search terms. RevMan 5.3.5 was used to conduct a random-effects meta-analysis using the inverse variance method for pooling risk ratios (RRs) or the Mantel-Haenszel method for pooling dichotomous data. Pooled data from >24,000 patients in randomized controlled trials and >475,000 patients from observational studies were used. The risk ratio (RR) for (any) stroke, using randomized controlled trial data, was not significant (RR 0.87, 95% CI 0.58-1.29). Using observational data, a significant difference favoring radial access was seen (RR 0.71, 95% CI 0.52-0.98).Conclusions: Radial access site utilization for cardiac catheterization is not associated with an increased risk of stroke events. These data provide reassurance and should remove another potential barrier to conversion to a "default" radial practice among those who are currently predominantly femoral operators. [ABSTRACT FROM AUTHOR]

Objectives The study sought to evaluate whether prophylactic ipsilateral ulnar artery compression during radial artery hemostasis could reduce the risk of radial artery occlusion (RAO). Background RAO after transradial access (TRA) is a structural complication of TRA. It limits future ipsilateral TRA and may cause transient pain. Maintaining radial artery flow during hemostasis reduces the incidence of acute RAO. Ipsilateral ulnar compression increases radial artery flow and could impact the incidence of RAO. Methods Three thousand patients undergoing diagnostic cardiac catheterization using TRA were randomized to receive either standard patent hemostasis protocol (Group I) or prophylactic ipsilateral ulnar compression in addition to patent hemostasis (Group II). Using plethysmography, radial artery patency was evaluated at the time of removal of the compression device as well as 24 h and 30 days after the procedure. The primary study endpoint was 30-day RAO. Results The primary endpoint, 30-day RAO, was significantly reduced in patients with patent hemostasis and prophylactic ulnar compression compared with standard patent hemostasis (0.9% vs. 3.0%; p = 0.0001). Baseline patient and procedural characteristics were similar between the 2 groups. RAO was significantly reduced by prophylactic ulnar compression at all time intervals (p < 0.0001). Conclusions Prophylactic ipsilateral ulnar compression during radial artery hemostasis is an effective, simple, and inexpensive technique that lowers the risk of RAO after TRA. [ABSTRACT FROM AUTHOR]

Objectives The aim of this study was to provide a quantitative appraisal of the effects on clinical outcomes of radial access for coronary interventions in patients with coronary artery disease (CAD). Background Randomized trials investigating radial versus femoral access for percutaneous coronary interventions have provided conflicting evidence. No comprehensive quantitative appraisal of the risks and benefits of each approach is available across the whole spectrum of patients with stable or unstable CAD. Methods The PubMed, Embase, Cochrane Central Register of Controlled Trials, and ClinicalTrials.gov databases were searched for randomized trials comparing radial versus femoral access for coronary interventions. Data were pooled by meta-analysis using a fixed-effects or a random-effects model, as appropriate. Pre-specified subgroup analyses according to clinical presentation, in terms of stable CAD, non–ST-segment elevation acute coronary syndromes, or ST-segment elevation myocardial infarction were performed. Results Twenty-four studies enrolling 22,843 participants were included. Compared with femoral access, radial access was associated with a significantly lower risk for all-cause mortality (odds ratio [OR]: 0.71; 95% confidence interval [CI]: 0.59 to 0.87; p = 0.001, number needed to treat to benefit [NNTB] = 160), major adverse cardiovascular events (OR: 0.84; 95% CI: 0.75 to 0.94; p = 0.002; NNTB = 99), major bleeding (OR: 0.53; 95% CI: 0.42 to 0.65; p < 0.001; NNTB = 103), and major vascular complications (OR: 0.23; 95% CI: 0.16 to 0.35; p < 0.001; NNTB = 117). The rates of myocardial infarction or stroke were similar in the 2 groups. Effects of radial access were consistent across the whole spectrum of patients with CAD for all appraised endpoints. Conclusions Compared with femoral access, radial access reduces mortality and MACE and improves safety, with reductions in major bleeding and vascular complications across the whole spectrum of patients with CAD. [ABSTRACT FROM AUTHOR]

Objectives This study sought to perform a randomized noninferiority trial of radiation exposure during cardiac catheterization comparing femoral access (FA) with left radial access (LRA) and right radial access (RRA). Background Increased radiation exposure with radial approach compared with femoral approach remains a controversial issue. Methods This study randomized 1,493 patients undergoing cardiac catheterization at a tertiary care center to FA, LRA, and RRA in a 1:1:1 fashion. The primary endpoint was air kerma. The secondary endpoints included dose-area product, fluoroscopy time and operator dose per procedure, number of cineangiograms, and number of catheters. Results Baseline and procedural characteristics were similar among groups. No significant differences were observed in air kerma (medians: FA: 421 mGy [interquartile range (IQR): 337 to 574 mGy], LRA: 454 mGy [IQR: 331 to 643 mGy], and RRA: 483 mGy [IQR: 382 to 592 mGy], p = 0.146), dose-area product (medians: FA: 25.5 Gy cm 2 [IQR: 19.6 to 34.5 Gy cm 2 ], LRA: 26.6 Gy cm 2 [IQR: 19.5 to 37.5 Gy cm 2 ], and RRA: 27.7 Gy cm 2 [IQR: 21.9 to 34.4 Gy cm 2 ], p = 0.40), or fluoroscopy time (medians: FA: 1.3 min [IQR: 1.0 to 1.7 min], LRA: 1.3 min [IQR: 1.0 to 1.7 min], and RRA: 1.32 min [IQR: 1.0 to 1.7 min], p = 0.19) among the 3 access sites. Median operator exposure was higher in the LRA group (3 mrem [IQR: 2 to 5 mrem], p = 0.001 vs. FA, and p = 0.0001 vs. RRA) compared with the FA (2 mrem [IQR: 2 to 4 mrem] and RRA groups (3 mrem [IQR: 2 to 5 mrem]). Conclusions Radiation exposure to patients was similar during diagnostic coronary angiography with FA, RRA, and LRA. However, LRA was associated with significantly higher operator radiation exposure than were FA and RRA procedures. (Randomized Evaluation of Vascular Entry Site and Radiation Exposure [REVERE]; NCT01677481 ) [ABSTRACT FROM AUTHOR]

Objectives: This study sought to determine the efficacy of low rate fluoroscopy at 7.5 frames/s (FPS) versus conventional 15 FPS for reduction of operator and patient radiation dose during diagnostic coronary angiography (DCA) and percutaneous coronary intervention (PCI) via the transradial approach (TRA). Background: TRA for cardiac catheterization is potentially associated with increased radiation exposure. Low rate fluoroscopy has the potential to reduce radiation exposure. Methods: Patients undergoing TRA diagnostic angiography ± ad-hoc PCI were randomized to fluoroscopy at 7.5 FPS versus 15 FPS prior to the procedure. Both 7.5 and 15 FPS fluoroscopy protocols were configured with a fixed dose per pulse of 40 nGy. Primary endpoints were operator radiation dose (measured with dosimeter attached to the left side of the thyroid shield in μSievert [μSv]), patient radiation dose (expressed as dose-area product in Gy·cm2), and fluoroscopy time. Results: From October 1, 2012 to August 30, 2013, from a total of 363 patients, 184 underwent DCA and 179 underwent PCI. Overall, fluoroscopy at 7.5 FPS compared with 15 FPS was associated with a significant reduction in operator dose (30% relative reduction [RR], p < 0.0001); and in patient's dose-area product (19% RR; p = 0.022). When stratified by procedure type, 7.5 FPS compared with 15 FPS was associated with significant reduction in operator dose during both DCA (40% RR; p < 0.0001) and PCI (28% RR; p = 0.0011). Fluoroscopy at 7.5 FPS, compared with 15 FPS, was also associated with substantial reduction in patients' dose-area product during DCA (26% RR; p = 0.0018) and during PCI (19% RR; p = 0.13). Fluoroscopy time was similar in 7.5 FPS and 15 FPS groups for DCA (3.4 ± 2.0 min vs. 4.0 ± 4.7 min; p = 0.42) and PCI (11.9 ± 8.4 min vs. 13.3 ± 9.7 min; p = 0.57), respectively. Conclusions: Fluoroscopy at 7.5 FPS, compared with 15 FPS, is a simple and effective method in reducing operator and patient radiation dose during TRA DCA and PCI. [Copyright &y& Elsevier]

Objectives: To study the causes of and to develop a risk score for failure of transradial approach (TRA) for percutaneous coronary intervention (PCI). Background: TRA-PCI failure has been reported in 5% to 10% of cases. Methods: TRA-PCI failure was categorized as primary (clinical reasons) or crossover failure. Multivariate analysis was performed to determine independent predictors of TRA-PCI failure, and an integer risk score was developed. Results: From January to June 2010, TRA-PCI was attempted in 1,609 (97.3%) consecutive patients, whereas 45 (2.7%) had primary TRA-PCI failure. Crossover TRA-PCI failure occurred in 30 (1.8%) patients. Causes of primary TRA-PCI failure included chronic radial artery occlusion (11%), previous coronary artery bypass graft (27%), and cardiogenic shock (20%). Causes for crossover TRA-PCI failure included: inadequate puncture in 17 patients (57%); radial artery spasm in 5 (17%); radial loop in 4 (13%); subclavian tortuosity in 2 (7%); and inadequate guide catheter support in 2 (7%) patients. Female sex (odds ratio [OR]: 3.2; 95% confidence interval [CI]: 1.95 to 5.26, p < 0.0001), previous coronary artery bypass graft (OR: 6.1; 95% CI: 3.63 to 10.05, p < 0.0001), and cardiogenic shock (OR: 11.2; 95% CI: 2.78 to 41.2, p = 0.0011) were independent predictors of TRA-PCI failure. Risk score values from 0 to 7 predicted a TRA-PCI failure rate from 2% to 80%. Conclusions: In a high-volume radial center, 2.7% of patients undergoing PCI are excluded from initial TRA on clinical grounds, whereas crossover to femoral approach is required in only 1.8% of the cases. A new simple clinical risk score is developed to predict TRA-PCI failure. [Copyright &y& Elsevier]

Objectives: PTOLEMY-2 was a prospective multicenter phase I single-arm feasibility trial to evaluate the second-generation permanent percutaneous transvenous mitral annuloplasty (PTMA) device in reducing functional mitral regurgitation (MR). Background: Percutaneous MR reduction has been performed through a direct method of clipping and securing the mitral leaflets together or an indirect approach of reducing mitral annular dimension via the coronary sinus. The PTMA device is the only coronary sinus mitral repair device without a static fixation element. Methods: Patients with at least moderate functional MR, New York Heart Association functional class II to IV, and left ventricular ejection fraction of 20% to 50% were enrolled at 14 centers in 5 countries. Device effects on patients were assessed by serial echocardiography, quality of life (QOL), and exercise capacity metrics. Results: A total of 43 patients were recruited, and 30 patients (70%) were implanted with a permanent PTMA device with a mean follow-up of 5.8 ± 3.8 months. The primary safety end point (freedom from death, myocardial infarction, stroke, or emergency surgery) at 30 days was met in 28 patients, whereas 2 patients died of device-related complications. The primary efficacy end point (MR reduction of at least 1.0 grade or reduction of regurgitant orifice area by 0.1 cm2 or regurgitant volume by 15 mL or regurgitant fraction by 10% compared with baseline) was obtained in 13 patients. No significant changes were noted in MR parameters, ventricular volumes, or QOL. Distance walked on 6 minutes testing at 6-month follow-up increased from 331 ± 167 m to 417 ± 132 m (P = .65). Compared with nonresponders, responders had a higher baseline regurgitant orifice area >0.2 cm2 (P = .001) and less prior history of myocardial infarction (P = .02), coronary artery bypass surgery (P = .03), and ischemic MR (P = .04). Conclusions: Overall, PTMA had mild impact on MR reduction, left ventricular remodeling, QOL, and exercise capacity. During follow-up, the risk/benefit ratio remained suboptimal. [Copyright &y& Elsevier]

Background: Although radial approach is increasingly used in percutaneous coronary interventions (PCIs) including in acute myocardial infarction (MI), patients with cardiogenic shock have been excluded from comparisons with femoral approach. The aim of our study was to compare clinical outcomes in patients undergoing primary PCI with cardiogenic shock by radial and femoral approach. Methods and Results: From 2,663 patients presenting with ST-elevation MI in 2 large volume radial centers, we identified 197 patients (7.4%) with signs of cardiogenic shock immediately before undergoing primary PCI. Radial approach was used in 55% of cases when at least 1 radial artery was weakly palpable, either spontaneously or after intravenous noradrenaline bolus. Patients in the radial group were older (69 ± 12 vs 64 ± 12 years, P = .010), had less diabetes (13% vs 26%, P = .028), and required less often intubation prior PCI (42% vs 66%, P = .0006) or intraaortic balloon pump (36% vs 55%, P = .0096). Mortality at 1 year was 44% in the radial group and 64% in the femoral group (P = .0044). Independent predictors of late mortality included radial approach (hazard ratio [HR] 0.65, 95% CI 0.42-0.98, P = .041), the use of glycoprotein IIb-IIIa receptor inhibitors (HR 0.63, 95% CI 0.40-0.96, P = .032), baseline creatinine ≥110 μmol/L (HR 3.34, 95% CI 2.20-5.12, P < .0001), initial glycemia >200 mg/dL (HR 2.02, 95% CI 1.34-3.11, P = .0008), and age >65 years (HR 1.80, 95% CI 1.18-2.79, P = .006). Conclusion: Radial approach was safe and feasible in more than half of the patients with ST-elevation MI and cardiogenic shock treated by primary PCI. After adjustment for baseline and procedural characteristics, radial approach remained associated with better survival. However, prognosis of patients undergoing primary PCI in cardiogenic shock remains poor. [Copyright &y& Elsevier]

Background: Transradial approach (TRA) for cardiac catheterizations and interventions improves clinical outcomes compared with transfemoral access, and its use is increasing worldwide. However, there are limited data on successive use of same artery for repeat procedures. Methods: Between May 2010 and May 2011, all consecutive patients undergoing a repeat TRA procedure (≥2) were retrospectively identified. Success rates and reasons for failure to use ipsilateral radial artery for repeat access were identified. Results: A total of 519 patients underwent 1,420 procedures. In 480 patients (92%), right radial artery was used as initial access, and left radial artery, in 39 patients. All patients underwent ≥2 procedures; 218 patients, ≥3; 87 patients, ≥4; 39 patients, ≥5; 19 patients, ≥6; 11 patients, ≥7; and 5 patients, ≥8 procedures. Two patients had, respectively, 9 and 10 procedures. The success rate for second attempt was 93%, 81% for third, and declining to 60% for ≥8. Linear regression analysis estimated a 5% failure rate for each repeat attempt (R 2 = 0.87, P = .007). The main reason for failure was related to clinical radial artery occlusion (RAO) including absent or faint pulse, poor oximetry, and failed puncture. All patients with clinical RAO were asymptomatic. By multivariate analysis, female gender (odds ratio [OR] 3.08, 95% CI 1.78-5.39, P < .0001), prior coronary artery bypass graft (OR 5.26, 95% CI 2.67-10.42, P < .0001), and repeat radial access (OR 2.14, 95% CI 1.70-2.76, P < .0001) were independent predictors of radial access failure. Conclusion: Successive TRA is both feasible and safe in most cases for up to 10 procedures. However, failure rate for TRA increases with successive procedures, primarily due to clinical RAO. Strategies to minimize the risks of chronic clinical RAO and allow repeat use of ipsilateral radial artery need to be further defined. [Copyright &y& Elsevier]

Objectives: This study sought to evaluate outcomes of same-day discharge (SDD) following percutaneous coronary intervention (PCI) versus overnight hospitalization (ON). Background: Although there are data on the safety and feasibility of SDD after PCI, ON continues to be prevalent. Methods: The Cochrane search strategy was used to search the PubMed database, EMBASE, and the Cochrane Library for relevant literature. Thirteen studies (5 randomized and 8 observational) of SDD after uncomplicated PCI versus ON met inclusion criteria. Data were pooled using a random effects model, and reported as odds ratios (OR) with their 95% confidence intervals (CI). The primary outcomes were incidence of total complications, major adverse cardiovascular events (MACE), and rehospitalization within 30 days after PCI. Results: A total of 13 studies, involving 111,830 patients were pooled. There was significant variation in the definition of outcomes across studies. For total complications, the strategy of SDD compared with ON after PCI had an estimated OR of 1.20 (95% CI: 0.82 to 1.74) in randomized and 0.67 (95% CI: 0.27 to 1.66) in observational studies. Similar results were found for MACE (randomized, OR: 0.99, 95% CI: 0.45 to 2.18; observational, OR: 0.59, 95% CI: 0.06 to 5.57) and rehospitalizations (randomized, OR: 1.10, 95% CI: 0.70 to 1.74; observational, OR: 0.62, 95% CI: 0.10 to 3.98) at 30 days post PCI. Conclusions: There is considerable heterogeneity across published studies comparing SDD with ON. This, coupled with the low event rate and wide corresponding CIs, suggest that an adequately powered multicenter randomized trial comparing SDD with ON would require a very large sample size (>17,000). Until such a trial is completed, SDD after uncomplicated PCI seems a reasonable approach in selected patients. [ABSTRACT FROM AUTHOR]

Background: The association between cardiogenic shock and 1 or >1 chronic total occlusion (CTO) in unselected patients presenting with ST-elevation myocardial infarction (MI) (STEMI) has not been characterized. Methods: Patients with STEMI referred with or without cardiogenic shock were categorized into no CTO, 1 CTO, and >1 CTO. The primary end point was the 30-day mortality. Results: Between 2006 and 2011, 2,020 consecutive patients were included. A total of 141 patients (7%) presented with cardiogenic shock on admission. The prevalence of 1 CTO and >1 CTO in a non–infarct-related artery was 23% and 5%, respectively, among patients with shock compared with 6% and 0.5% in patients without shock (P < .0001). Independent predictors of cardiogenic shock included left main–related MI (odds ratio [OR] 6.55, 95% CI 1.39-26.82, P = .019), CTO (OR 4.20, 95% CI 2.64-6.57, P < .001), creatinine clearance <60 mL/min (OR 3.41, 95% CI 2.32-4.99, P < .0001), and left anterior descending–related MI (OR 2.20, 95% CI 1.51-3.23, P < .0001). Thirty-day mortality was 100% in shock patients with >1 CTO, 65.6% with 1 CTO, and 40.2% in patients without CTO (P < .0001). After adjustment for left ventricular ejection fraction and renal function, CTO remained an independent predictor for 30-day mortality (hazard ratio [HR] 1.83; 95% CI 1.10-3.01, P = .02). Conclusion: In patients with STEMI, CTO was strongly associated with cardiogenic shock on admission. In this setting, mortality was substantially higher in patients with 1 CTO and exceedingly high in those with >1 CTO. The presence of CTO was an independent predictor of early mortality. [ABSTRACT FROM AUTHOR]

With femoral access, bivalirudin decreases risks of major bleeding after percutaneous coronary intervention (PCI) and provides better net clinical benefit compared to unfractionated heparin (UFH) plus planned glycoprotein IIb/IIIa inhibitors. Whether this benefit exists compared to UFH monotherapy is less clear. We performed a systematic review and meta-analysis to compare outcomes in patients undergoing transfemoral PCI with UFH or bivalirudin. Randomized trials (n = 3) and observational studies (n = 13) comparing bivalirudin to UFH monotherapy were reviewed. Primary outcomes were 30-day rates of major adverse cardiovascular events (MACEs) including death, myocardial infarction (MI), urgent revascularization, as well as all-cause mortality, MI, major bleeding, and blood transfusion. We collected data from 16 studies involving 32,492 patients undergoing PCI. Most observational studies were performed in the United States, whereas all randomized trials were done in Europe. Compared to UFH monotherapy, bivalirudin was associated with similar risk of MACEs (odds ratios [OR] 0.92, 95% confidence interval [CI] 0.75 to 1.12), a substantial 45% relative decrease in major bleeding (OR 0.55, 95% CI 0.43 to 0.72), and a trend in the decrease of transfusion (OR 0.87, 95% CI 0.70 to 1.08). A decrease in mortality was seen in observational studies (OR 0.62, 95% CI 0.45 to 0.85) but remained inconclusive in randomized trials (OR 0.63, 95% CI 0.20 to 2.01). MI rate was similar with the 2 anticoagulants. In conclusion, in patients undergoing transfemoral PCI, the benefit of bivalirudin over UFH monotherapy is driven by a significant decrease in major bleeding with similar rates of MACE. As PCI practice moves toward other bleeding-avoidance strategies such as the radial approach, future studies should focus on the interaction between anticoagulant strategy and access-site choice. [ABSTRACT FROM AUTHOR]

Systemic anticoagulation decreases the risk of radial artery occlusion (RAO) after transradial catheterization and standard occlusive hemostasis. We compared the efficacy and safety of provisional heparin use only when the technique of patent hemostasis was not achievable to standard a priori heparin administration after radial sheath introduction. Patients referred for coronary angiography were randomized in 2 groups. In the a priori group, 200 patients received intravenous heparin (50 IU/kg) immediately after sheath insertion. In the provisional group, 200 patients did not receive heparin during the procedure. After sheath removal, hemostasis was obtained using a TR band (Terumo corporation, Tokyo, Japan) with a plethysmography-guided patent hemostasis technique. In the provisional group, no heparin was given if radial artery patency could be obtained and maintained. If radial patency was not achieved, a bolus of heparin (50 IU/kg) was given. Radial artery patency was evaluated at 24 hours (early RAO) and 30 days after the procedure (late RAO) by plethysmography. Patent hemostasis was obtained in 67% in the a priori group and 74% in the provisional group (p = 0.10). Incidence of RAO remained similar in the 2 groups at the early (7.5% vs 7.0%, p = 0.84) and late (4.5% vs 5.0%, p = 0.83) evaluations. Women, patients with diabetes, patients having not received heparin, and patients without radial artery patency during hemostasis had more RAO. By multivariate analysis, patent radial artery during hemostasis (odds ratio [OR] 0.03, 95% confidence interval [CI] 0.004 to 0.28, p = 0.002) and diabetes (OR 11, 95% CI 3 to 38,p <0.0001) were independent predictors of late RAO, whereas heparin was not (OR 0.45 95% CI 0.13 to 1.54, p = 0.20). In conclusion, our results suggest that maintenance of radial artery patency during hemostasis is the most important parameter to decrease the risk of RAO. In selected cases, provisional use of heparin appears feasible and safe when patent hemostasis is maintained. [Copyright &y& Elsevier]

Background: Despite lower risks of access site–related complications with transradial approach (TRA), its clinical benefit for percutaneous coronary intervention (PCI) is uncertain. We conducted a systematic review and meta-analysis of clinical studies comparing TRA and transfemoral approach (TFA) for PCI. Methods: Randomized trials and observational studies (1993-2011) comparing TRA with TFA for PCI with reports of ischemic and bleeding outcomes were included. Crude and adjusted (for age and sex) odds ratios (OR) were estimated by a hierarchical Bayesian random-effects model with prespecified stratification for observational and randomized designs. The primary outcomes were rates of death, combined incidence of death or myocardial infarction, bleeding, and transfusions, early (≤30 days) and late after PCI. Results: We collected data from 76 studies (15 randomized, 61 observational) involving a total of 761,919 patients. Compared with TFA, TRA was associated with a 78% reduction in bleeding (OR 0.22, 95% credible interval [CrI] 0.16-0.29) and 80% in transfusions (OR 0.20, 95% CrI 0.11-0.32). These findings were consistent in both randomized and observational studies. Early after PCI, there was a 44% reduction of mortality with TRA (OR 0.56, 95% CrI 0.45-0.67), although the effect was mainly due to observational studies (OR 0.52, 95% CrI 0.40-0.63, adjusted OR 0.49 [95% CrI 0.37-0.60]), with an OR of 0.80 (95% CrI 0.49-1.23) in randomized trials. Conclusion: Our results combining observational and randomized studies show that PCI performed by TRA is associated with substantially less risks of bleeding and transfusions compared with TFA. Benefit on the incidence of death or combined death or myocardial infarction is found in observational studies but remains inconclusive in randomized trials. [ABSTRACT FROM AUTHOR]

The radial approach in primary percutaneous coronary intervention (PCI) has been recently assessed in both randomized and observational studies. However, observational studies have several biases that favor the radial approach. We conducted a meta-analysis of randomized controlled trials to compare the clinical outcomes of radial and femoral approach in primary PCI for ST-segment elevation myocardial infarction. The outcomes of interest included death, major bleeding, vascular complications/hematoma, and procedure time. The data were pooled using random-effects models. Ten randomized controlled trials involving 3,347 patients met our inclusion criteria. The radial approach was associated with improved survival (odds ratio 0.53, 95% confidence interval 0.33–0.84) and reduced vascular complications/hematoma (odds ratio 0.35, 95% confidence interval 0.24–0.53). A nonsignificant trend was found toward reduced major bleeding with the radial approach (odds ratio 0.63, 95% confidence interval 0.35–1.12). The procedural time with the radial approach was longer by <2 minutes (mean difference 1.76 minutes, 95% confidence interval 0.59–2.92). In conclusion, in patients undergoing primary PCI, the radial approach is associated with lower short-term mortality. When feasible, the radial approach should be the favored route in primary PCI. [ABSTRACT FROM AUTHOR]

Radial artery occlusion (RAO) can result from transradial catheterization. We compared the incidence of RAO with 2 heparin dosage regimens after transradial coronary angiography, and we evaluated the efficacy and safety of transient homolateral ulnar artery compression to achieve acute radial artery recanalization. Patients referred for coronary angiography were randomized to very-low-dose heparin (2,000 IU) or low-dose heparin (5,000 IU). On sheath removal, hemostasis was obtained using the TR band with a plethysmography-guided patent hemostasis technique. In the case of RAO as assessed by duplex ultrasonography 3 to 4 hours after hemostasis, immediate 1-hour ulnar artery compression was applied. Hematomas >15 cm2 were also assessed. We randomized 465 patients, 222 in the 2,000-IU group and 243 in the 5,000-IU group. The baseline and procedural characteristics were comparable in both groups. The incidence of initial RAO was 5.9% in the 2,000-IU group and 2.9% in the 5,000-IU group (p = 0.17), with a compression time of 2.10 ± 0.78 hours and 2.25 ± 0.82 hours, respectively (p = 0.051). After ulnar artery compression, the final incidence of RAO was 4.1% in the 2,000-IU group and 0.8% in the 5,000-IU group (p = 0.03). The incidence of local hematoma was 2.3% and 3.7% in the 2,000- and 5,000-IU groups, respectively (p = 0.42). In conclusion, acute RAO after transradial catheterization can be recanalized by early 1-hour homolateral ulnar artery compression. This simple nonpharmacologic method was effective and safe in patients with very-low- and low-dose heparin. Nevertheless, the incidence of final RAO remained significantly lower after a higher anticoagulation level. [ABSTRACT FROM AUTHOR]

Background: Very few data exist on the functional evaluation of patients with severe symptomatic aortic stenosis undergoing transcatheter aortic valve implantation (TAVI). The aims of this prospective study were (1) to evaluate the Duke Activity Status Index (DASI) as a measure of functional status pre-TAVI and post-TAVI, (2) to determine the clinical parameters associated with DASI changes after TAVI, and (3) to compare functional status as evaluated by DASI and the New York Heart Association (NYHA) class with exercise capacity as evaluated by the 6-minute walk test (6MWT) in such patients. Methods: A total of 76 patients (80 ± 8 years old) who underwent successful TAVI were included. All patients completed the DASI self-questionnaire at baseline and at 6 months after TAVI, and 46 patients also performed a 6MWT. Results: The mean DASI increased from 10.3 ± 5.4 to 16.3 ± 8.3 at 6 months after TAVI (P < .0001). However, the DASI did not change or even decreased to some extent in 30% of patients after TAVI. Renal dysfunction as evaluated by the estimated glomerular filtration rate was identified as the independent predictor of DASI impairment after TAVI (OR 1.7 for each decrease in estimated glomerular filtration rate of 10 mL/min/1.73 m2, 95% CI 1.3-2.3, P = .005). The mean distance walked increased from 165.9 ± 77.6 to 211.8 ± 78.7 m (P = .0001) at follow-up. The DASI showed a good correlation with the distance walked at baseline (r = 0.55, P < .0001) and at follow-up (r = 0.66, P < .0001). The NYHA class improved to some degree in all but 5 patients; however, the NYHA class did not correlate with the results of DASI and the 6MWT. Conclusions: Transcatheter aortic valve implantation was associated with a significant increase in functional status at 6-month follow-up as evaluated by the DASI, although no improvement was observed in about one third of patients. The presence of baseline renal dysfunction better determined this lack of improvement in functional status. The DASI, but not the NYHA class, correlated with distance walked in the 6MWT. These results suggest that the DASI might become a useful tool for evaluating both candidates for and the impact of TAVI procedures. [Copyright &y& Elsevier]

Objectives: The aim of this study was to: 1) determine the usefulness of transesophageal echocardiography (TEE) as the primary technique to guide transapical (TA) transcatheter aortic valve implantation (TAVI); and 2) to compare TEE with angiography as the primary imaging modality for TA-TAVI guidance. Background: TEE has been routinely used as an adjunct to angiography during TA-TAVI procedures, but very few data exist on the use of TEE as the primary imaging technique guiding TA-TAVI. Methods: One hundred consecutive high-risk patients (mean age 79 ± 9 years, mean logistic EuroSCORE: 25.8 ± 17.6%) who underwent TA-TAVI in our center were included. The Edwards valve was used in all cases, and all procedures were performed in an operating room without hybrid facilities. The TA-TAVI was primarily guided by angiography in the first 25 patients (A-TAVI group) and by TEE in the last 75 patients (TEE-TAVI group). Procedural, 30-day, and follow-up results were evaluated. Results: No differences were observed between groups at baseline except for a higher (p = 0.001) prevalence of moderate or severe mitral regurgitation in the TEE-TAVI group. The procedure was successful in 97.3% and 100% of the patients in the TEE-TAVI and A-TAVI groups, respectively (p = 1.0), and a lower contrast volume was used in the TEE-TAVI group (12 [5 to 20] ml vs. 40 [20 to 50] ml, p < 0.0001). There were no differences between groups in the occurrence of valve malposition needing a second valve (TEE-TAVI: 5.3%; A-TAVI: 4%; p = 1.0) or valve embolization (TEE-TAVI: 1.3%; A-TAVI: 4%; p = 0.44). The results regarding post-procedural valve hemodynamic status and aortic regurgitation were similar between groups. The survival rates at 30-day and 1-year follow-up were 87% and 75% in the TEE-group and 88% and 84% in the A-TAVI group, respectively (log-rank = 0.49). Conclusions: TEE-TAVI was associated with similar acute and midterm results as A-TAVI and significantly reduced contrast media use during the procedures. These results suggest the feasibility and safety of performing TA-TAVI procedures in an operating room without hybrid facilities, but larger studies are needed to confirm these findings. [Copyright &y& Elsevier]

Objectives: The aim of this study was to evaluate practice of transradial approach (TRA). Background: TRA has been adopted as an alternative access site for coronary procedures. Methods: A questionnaire was distributed worldwide with Internet-based software. Results: The survey was conducted from August 2009 to January 2010 among 1,107 interventional cardiologists in 75 countries. Although pre-TRA dual hand circulation testing is not uniform in the world, >85% in the U.S. perform Allen or oximetry testing. Right radial artery is used in almost 90%. Judkins catheters are the most popular for left coronary artery angiographies (66.5%) and right coronary artery angiographies (58.8%). For percutaneous coronary intervention (PCI), 6-F is now standard. For PCI of left coronary artery, operators use standard extra back-up guiding catheters in >65% and, for right coronary artery 70.4% use right Judkins catheters. Although heparin remains the routine antithrombotic agent in the world, bivalirudin is frequently used in the U.S. for PCI. The incidence of radial artery occlusion before hospital discharge is not assessed in >50%. Overall, approximately 50% responded that their TRA practice will increase in the future (68.4% in the U.S.). Conclusions: TRA is already widely used across the world. Diagnostic and guiding-catheters used for TRA remain similar to those used for traditional femoral approach, suggesting that specialized radial catheters are not frequently used. However, there is substantial variation in practice as it relates to specific aspects of TRA, suggesting that more data are needed to determine the optimal strategy to facilitate TRA and optimize radial artery patency after catheterization. [ABSTRACT FROM AUTHOR]

Objectives: This study sought to estimate the economic impact of same-day home discharge compared with overnight hospitalization after transradial percutaneous coronary intervention (PCI). Background: Same-day home discharge after transradial PCI and a bolus-only abciximab regimen was found to be clinically noninferior to the abciximab standard therapy and overnight hospitalization in patients with various forms of acute coronary syndromes. Methods: In the EASY (Early Discharge After Transradial Stenting of Coronary Arteries) trial, 1,005 patients were randomized after a bolus of abciximab and uncomplicated transradial coronary stenting, either to same-day home discharge and no infusion (outpatient group) or to overnight hospitalization and 12-h abciximab infusion (overnight-stay group). We estimated post-PCI health care cost (in Canadian dollars) of trial subjects and short-term economic impact of same-day home discharge. As randomization was done after the procedure, outcomes were similar, and PCI resource use showed minimal and nonsignificant differences, a post-PCI cost-minimization analysis was conducted. Detailed per-patient information of health care resources used immediately after PCI up to 30 days was collected. Results: Mean post-PCI hospital stay was 8.9 h for outpatients versus 26.5 h for overnight-stay patients (p < 0.001). At 30-day follow-up, the mean cumulative medical cost per outpatient was $1,117 ± $1,554 versus $2,258 ± $1,328 for overnight-stay patients. The mean difference of $1,141 (95% confidence interval: $962 to $1,320) was mainly due to the extra night for overnight hospital stay. Conclusions: In a real-world setting, same-day home discharge after uncomplicated transradial PCI and a bolus-only abciximab regimen resulted in a 50% relative reduction in medical costs. Extension of this outpatient strategy would be welcomed by the hospitals and reimbursement systems in a context of increasing demand for health care cost reduction. (Early Discharge After Transradial Stenting of Coronary Arteries [EASY]; NCT00169819) [Copyright &y& Elsevier]

Abstract: Objectives: To assess the efficacy and safety of rosiglitazone on saphenous vein graft (SVG) atherosclerosis prevention and on modification of the global cardiometabolic risk profile. Methods and results: This was a double-blind, randomized, placebo-controlled, multicenter trial which enrolled 193 post-CABG patients with type 2 diabetes. Atherosclerosis changes in one SVG were assessed with intravascular ultrasound at baseline and at 12 months. Serial cardiometabolic assessments were performed. At baseline, both groups had mean HbA1C <7%, LDL-cholesterol (LDL-C)<2.3mmol/l, HDL-cholesterol (HDL-C)>1.0mmol/l and blood pressure<130/75 mmHg. After 12 months, plaque volume in SVG had increased (median [interquartile range]) by 7.7mm3 (−17.2 to 37.9) in the placebo group and decreased by 0.3mm3 (−19.1 to 22.3) in the rosiglitazone group (P =0.22). Compared to placebo, rosiglitazone treated patients had a higher (mean±SD) body weight (89±15kg vs. 84±15kg, P =0.02) at the end of the study, mostly related to an increment in subcutaneous adipose tissue. Rosiglitazone treated patients also displayed further improvements in glycemic control compared to placebo (HbA1C: 6.4±0.7% vs. 7.0±0.9%, P <0.001) as well as in several cardiometabolic parameters such as lipids (HDL-C: 1.16±0.28mmol/l vs. 1.06±0.23mmol/l, P =0.003), inflammatory profile (C-reactive protein: 0.92mg/l [0.51–1.56] vs. 1.37mg/l [0.79–3.08], P =0.02), and adiponectin levels (11.1μg/ml [8.19–17.9] vs. 4.65μg/ml [3.27–7.15], P <0.001). There was no significant difference in the incidence of serious adverse cardiovascular events. However, more patients in the rosiglitazone group had peripheral oedema (33% vs. 18%, P =0.0019). Conclusion: After a 12-month follow-up, we found no evidence for a statistically significant effect of rosiglitazone on SVG atherosclerosis whereas significant effects on glycemic control and on the cardiometabolic risk profile appeared to be modulated in part by changes in subcutaneous adiposity. [Copyright &y& Elsevier]

Anemia and major bleeding are independent predictors of outcomes after acute coronary syndromes and percutaneous coronary intervention (PCI). Although the transradial approach reduces the incidence of bleeding, the hemoglobin changes after transradial PCI have not been defined. We serially assessed the hemoglobin values before and after transradial PCI and evaluated the effect of hemoglobin changes on outcomes. In the EArly Discharge After Transradial Stenting of CoronarY Arteries (EASY) trial, 1,348 patients underwent transradial PCI. All patients received aspirin, clopidogrel, and a bolus of abciximab before PCI. The hemoglobin values were assessed immediately before and 4 to 6 hours and 12 to 24 hours after PCI. The major adverse cardiac events (death, myocardial infarction, and target vessel revascularization) were assessed ≤3 years after PCI. According to the World Health Organization classification, 206 patients (15%) had anemia before PCI and 410 (30%) developed anemia within 24 hours after PCI. A mean hemoglobin decrease of 0.6 ± 1.0 g/dl occurred within 24 hours after PCI. At 30 days, the major adverse cardiac events were significantly increased when the hemoglobin decrease within 24 hours after PCI was >3 g/dl (p = 0.0002). Patients with anemia within 24 hours after PCI had significantly more major adverse cardiac events at 30 days, 6 months, 1 year, and 3 years than patients without anemia (log-rank p = 0.0044). After adjustment for differences in the baseline characteristics, anemia within 24 hours after PCI remained an independent predictor of major averse cardiac events at 3 years (hazard ratio 1.30, 95% confidence interval 1.01 to 1.67, p = 0.045). In conclusion, within 24 hours after transradial PCI with maximal antiplatelet therapy, only a mild hemoglobin decrease was observed. The choice of a hemoglobin decrease >3 g/dl after PCI as a cutoff value for current definitions of major bleeding in modern PCI trials appears reasonable. Measures to prevent anemia and blood loss during PCI remain to be further studied. [Copyright &y& Elsevier]

Platelet aggregation inhibition (PAI) of ≥95% has been associated with improved outcomes after percutaneous coronary intervention (PCI) and glycoprotein IIb/IIIa inhibitor treatment. A greater thrombotic burden in acute ST-segment elevation myocardial infarction (STEMI) might require higher doses and/or intracoronary delivery of glycoprotein IIb/IIIa inhibitors to achieve optimal PAI. Using a 2 × 2 factorial placebo-controlled design, 105 patients with STEMI who had been referred for primary PCI within 6 hours of symptom onset were randomized to intracoronary (IC) or intravenous (IV) delivery of an abciximab bolus at a standard dose (0.25 mg/kg) or high dose (≥0.30 mg/kg) of abciximab. The primary end point was PAI measured at 10 minutes after the bolus of abciximab. Secondary end points included the acute and 6-month outcomes using angiographic parameters, cardiac biomarkers, cardiovascular magnetic resonance imaging, and clinical end points. At 10 minutes after the bolus, the proportion of patients with ≥95% PAI was not different between the IC and IV groups (53% vs 54%, p = 1.00) nor between the high-dose and standard-dose bolus groups (56% vs 51%, p = 0.70). Acutely, the angiographic myocardial blush grades, peak release of cardiac biomarkers, necrosis size, myocardial perfusion, and no reflow as assessed by magnetic resonance imaging, and clinical end points were similar between the groups and did not suggest a benefit for IC compared to IV or high-dose versus standard-dose bolus of abciximab. No increase occurred in bleeding complications with the high-dose bolus or IC delivery. The clinical, angiographic and cardiac magnetic resonance imaging outcomes at 6 and 12 months were similar between the 4 groups. In conclusion, in patients with STEMI presenting with symptom onset <6 hours and undergoing transradial primary PCI, PAI remained suboptimal, despite a higher dose bolus of abciximab. A higher dose bolus or IC delivery of abciximab bolus was not associated with improved acute or late results compared to the standard IV dosing and administration. [Copyright &y& Elsevier]

Abstract: In this review, we examine the contribution of human electrophysiological studies (EEG, sEEG and MEG) to the study of visual influence on processing in the auditory cortex. Focusing mainly on studies performed by our group, we critically review the evidence showing (1) that visual information can both activate and modulate the activity of the auditory cortex at relatively early stages (mainly at the processing stage of the auditory N1 wave) in response to both speech and non-speech sounds and (2) that visual information can be included in the representation of both speech and non-speech sounds in auditory sensory memory. We describe an important conceptual tool in the study of audiovisual interaction (the additive model) and show the importance of considering the spatial distribution of electrophysiological data when interpreting EEG results. Review of these studies points to the probable role of sensory, attentional and task-related factors in modulating audiovisual interactions in the auditory cortex. [Copyright &y& Elsevier]

The optimal value of activated clotting time (ACT) during percutaneous coronary intervention (PCI) with unfractionated heparin remains controversial. No data are available on the relation between the ACT at the end of the procedure (final ACT) and the clinical outcomes after transradial PCI and maximal antiplatelet therapy. By dividing the final ACT values in tertiles, we analyzed the ischemic and bleeding events in 1,234 consecutive patients with acute coronary syndrome recruited in the EArly Discharge after Transradial Stenting of CoronarY Arteries (EASY) trial. All patients were pretreated with aspirin and clopidogrel. After radial sheath insertion, patients received 70 IU/kg unfractionated heparin. Abciximab was given before the first balloon inflation. The median final ACT value was 312 seconds (interquartile range 279 to 344). At 30 days, the rate of major adverse cardiac events, including death, myocardial infarction, and target vessel revascularization, from the lower to upper tertiles was 4%, 4%, and 2%, respectively (p = 0.16), and the rate of major bleeding was 2%, 1% and 0.7%, respectively (p = 0.20). During the 3 years of follow-up, the incidence of myocardial infarction was less in the tertile with the greatest ACT value (>330 seconds) than in the other 2 tertiles (4%, 8%, and 8%, respectively; p = 0.038). Troponin-T and creatine kinase-MB release after PCI indicated that the effect was related to periprocedural myonecrosis protection. After adjustment for baseline and procedural differences, a final ACT of >330 seconds remained associated with a 47% relative reduction in myocardial infarction (odds ratio 0.53, 95% confidence interval 0.29 to 0.93, p = 0.024). Death and target vessel revascularization remained similar in all tertiles for ≤3 years. In conclusion, with the combination of aspirin, clopidogrel pretreatment, and abciximab, a final ACT value of >330 seconds appears protective against peri-PCI myonecrosis, and this benefit was maintained for ≤3 years. With a transradial approach and maximal antiplatelet therapy, greater ACT values did not correlate with an increased risk of bleeding. [Copyright &y& Elsevier]

Elderly patients are at a higher risk for complications after percutaneous coronary intervention (PCI) when performed through the femoral approach. The impact of age on complications in patients treated using the transradial approach is not known. The bleeding and ischemic outcomes at 30 days, 6 months, 1 year, and 3 years after transradial PCI and maximal antiplatelet therapy were compared in 1,348 patients aged <70 or ≥70 years with acute coronary syndromes. All patients received aspirin and clopidogrel before catheterization, followed by abciximab at the time of PCI. Patients aged ≥70 years (n = 259 [19%]) had more hypertension, dyslipidemia, family histories, and previous coronary artery bypass grafting. Older patients had lower baseline hemoglobin, platelet, and creatinine clearance values, and they also more often had 2- or 3-vessel syndrome (p = 0.001), as well as longer procedure durations (p = 0.024). At 30 days, the rates of major adverse cardiac events and major bleeding were similar in older and younger patients. Only the incidence of gastrointestinal bleeding (p = 0.021) and mild to moderate access-site hematoma were higher in older patients (p = 0.036). The rates of major adverse cardiac events were also similar in the 2 age groups at 6 months (6% vs 9%, p = 0.08), 1 year (10% vs 13%, p = 0.22), and 3 years (19% vs 20%, p = 0.73), but mortality was significantly higher at 3 years in patients aged ≥70 years (p = 0.0031). In conclusion, age per se is not a predictor of major adverse cardiac events or major bleeding after transradial PCI with maximal antiplatelet therapy. However, older patients remain more prone to gastrointestinal bleeding and local hematoma compared to younger patients, and preventive measures need to be further investigated. [Copyright &y& Elsevier]

Abstract: Background: In the EASY trial, we have shown the clinical equivalence between abciximab bolus-only and abciximab bolus followed by 12-h infusion in a wide spectrum of patients after percutaneous coronary intervention (PCI). Some reports have suggested better outcomes following intracoronary (IC) abciximab administration compared to intravenous (IV) delivery. We sought to compare cardiac biomarkers release and early and late clinical outcomes after IC or IV abciximab bolus delivery. Methods: From 1005 patients randomized in the EASY trial and undergoing transradial coronary stent implantation, 208 received IC abciximab bolus and 797 received IV abciximab bolus. Route of administration was left to operators'' discretion. Creatine Kinase-MB, and Troponin-T (Tn-T) were obtained immediately prior to angiography, 4–6 h after PCI and the next day. MACE (death, MI, TVR) rate was evaluated at 30 days, 6 months and 12 months. Results: There were more patients with acute coronary syndrome (75% vs 64%, P =0.004) and previous MI (53% vs 42%, P =0.005) in the IC group and more patients with ≥3 dilated sites in the IV group (2% IC vs 7% IV, P =0.03). After PCI, the extent of Tn-T and CK-MB release remained comparable in both groups. The MACE rate was 2% in both groups at 30 days, 9% in IC bolus vs 5% in IV bolus (P =0.04) at 6 months and 10% in IC bolus vs 9% in IV bolus (P =0.50) at 12 months. By multivariate analysis, IC abciximab bolus was not associated with better outcomes at 12 months compared to IV bolus (HR 1.07, 95% CI 0.82–1.35, P =0.62). Conclusion: Compared to IV abciximab administration, IC abciximab was not associated with less cardiac biomarkers release or better clinical outcomes after uncomplicated transradial PCI. Further studies are required in clinical scenarios including patients with higher thrombotic burden and/or occluded vessels as in primary and rescue PCI. [Copyright &y& Elsevier]

Background: Transapical aortic valve implantation (TAVI) for the treatment of severe aortic stenosis requires the insertion of a large catheter through the left ventricular apex. However, the electrocardiographic (ECG) changes associated with the incision and repair of the left ventricular apex and the potential damage to the conduction system caused by implanting a balloon-expandable valve in aortic position are not known. The objective of our study was to determine the incidence, type, and timing of ECG changes associated with TAVI. Methods: The standard 12-lead ECGs of 33 consecutive patients (mean age 81 ± 9 years, 13 men) diagnosed with symptomatic severe aortic stenosis (valve area 0.62 ± 0.16 cm2) who underwent TAVI with an Edwards-SAPIEN valve were analyzed at baseline (within 24 hours before the procedure), immediately (within 6 hours) after the procedure, at hospital discharge, and at 1-month follow-up. Results: There were no procedural deaths, and 30-day mortality was 6%. The incidence of complete left ventricular branch block (LBBB) and left anterior hemiblock (LAHB) increased from 9% and 3% at baseline to 27% and 36% after the procedure, respectively (P < .03 for both). A lower (ventricular) position of the valve relative to the hinge point of the anterior mitral leaflet was associated with a higher incidence of new LBBB (35% vs 0%, P = .029); and a greater valve size–aortic annulus ratio, with the occurrence of new LAHB (1.20 ± 0.07 vs 1.14 ± 0.06, P = .021). At 1-month follow-up, the rate of LBBB and LAHB decreased to 13% and 10%, respectively (P = not significant compared with baseline). There were no cases of new atrioventricular block, and no patient needed pacemaker implantation. Transient (<48 hours) ST-elevation changes, mostly in the anterior and/or lateral leads, occurred in 6 patients (18%) immediately after the procedure; but only 1 of these patients presented new Q waves at 1-month follow-up. Conclusions: Transapical aortic valve implantation was associated with a significant but transient (<1 month) increase in LBBB and LAHB, with no patient requiring pacemaker implantation. These changes were partially related to both lower (more ventricular) valve positioning and greater valve oversizing. Transient (<48 hours) ST-segment elevation changes occurred in about one fifth of the patients after the procedure, but only a minority developed new Q waves in the ECG. [Copyright &y& Elsevier]

Background: Female gender has been associated with poorer outcomes after percutaneous coronary intervention (PCI) and femoral approach. However, no data are available on the impact of gender and transradial PCI with maximal antiplatelet therapy on bleeding and ischemic outcomes. Methods: In the EArly discharge after Stenting of coronarY arteries (EASY) trial, 1,348 patients with acute coronary syndrome underwent transradial PCI. All patients were pretreated with aspirin and clopidogrel. After sheath insertion, 70 U/kg heparin was administered and a bolus of abciximab was given before first balloon inflation. Major adverse cardiac events including death, myocardial infarction, and target vessel revascularization; major bleeding; and local hematomas were evaluated at 30 days, 6 months, and 12 months. Results: Women (n = 298, 22%) were older, had more hypertension, more family history, and less previous PCI than men. Weight, baseline hemoglobin, and creatinine clearance were significantly lower in women. The number of dilated sites, complex lesions, and procedure duration was similar, but 5F sheath size was more frequent in women. Major adverse cardiac events remained similar at 30 days (3.4% vs 3.9%, P = .86), at 6 months (11.5% vs 7.8%, P = .06), and at 1 year (14.1% vs 12.6%) in both groups. There was no significant difference in the incidence of major bleeding between the 2 groups, but female gender was the only independent predictor of hematomas (odds ratio 4.40, 95% confidence interval 2.49-7.81, P < .0001). Conclusion: Despite more comorbidities, female gender was not a predictor of adverse clinical outcomes after transradial PCI with maximal antiplatelet therapy. Still, female gender remained associated with a higher risk of local hematomas. Efforts should continue to identify modifiable factors to reduce procedural bleeding in women, regardless of the access site. [Copyright &y& Elsevier]