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.
CONTEXT High platelet reactivity while receiving clopidogrel has been linked to cardiovascular events after percutaneous coronary intervention (PCI), but a treatment strategy for this issue is not ...well defined. OBJECTIVE To evaluate the effect of high-dose compared with standard-dose clopidogrel in patients with high on-treatment platelet reactivity after PCI. DESIGN, SETTING, AND PATIENTS Randomized, double-blind, active-control trial (Gauging Responsiveness with A VerifyNow assay—Impact on Thrombosis And Safety GRAVITAS) of 2214 patients with high on-treatment reactivity 12 to 24 hours after PCI with drug-eluting stents at 83 centers in North America between July 2008 and April 2010. INTERVENTIONS High-dose clopidogrel (600-mg initial dose, 150 mg daily thereafter) or standard-dose clopidogrel (no additional loading dose, 75 mg daily) for 6 months. MAIN OUTCOME MEASURES The primary end point was the 6-month incidence of death from cardiovascular causes, nonfatal myocardial infarction, or stent thrombosis. The key safety end point was severe or moderate bleeding according to the Global Utilization of Streptokinase and t-PA for Occluded Coronary Arteries (GUSTO) definition. A key pharmacodynamic end point was the rate of persistently high on-treatment reactivity at 30 days. RESULTS At 6 months, the primary end point had occurred in 25 of 1109 patients (2.3%) receiving high-dose clopidogrel compared with 25 of 1105 patients (2.3%) receiving standard-dose clopidogrel (hazard ratio HR, 1.01; 95% confidence interval CI, 0.58-1.76; P = .97). Severe or moderate bleeding was not increased with the high-dose regimen (15 1.4% vs 25 2.3%, HR, 0.59; 95% CI, 0.31-1.11; P = .10). Compared with standard-dose clopidogrel, high-dose clopidogrel provided a 22% (95% CI, 18%-26%) absolute reduction in the rate of high on-treatment reactivity at 30 days (62%; 95% CI, 59%-65% vs 40%; 95% CI, 37%-43%; P < .001). CONCLUSIONS Among patients with high on-treatment reactivity after PCI with drug-eluting stents, the use of high-dose clopidogrel compared with standard-dose clopidogrel did not reduce the incidence of death from cardiovascular causes, nonfatal myocardial infarction, or stent thrombosis. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00645918
Objectives
To gain insight into current practice of transradial angiography and intervention in the United States and around the world.
Background
Transradial access (TRA) has grown worldwide. In a ...prior survey, there was significant practice variation and there was minimal US participation which limited the generalizability to US operators.
Methods
We used an internet‐based survey software program to solicit input from practicing interventional cardiologists from the United States and around the world. US operators were compared with outside the United States (OUS) operators and respondent‐level comparisons were made with the prior survey to assess for temporal changes in practice.
Results
Between August 2016 and January 1, 2017, 125 interventional cardiologists completed the survey representing 91 countries with the United States having 449 (39.9%) respondents. Preprocedure, noninvasive testing for collateral circulation is used more commonly in the United States (54.1%) than around the world (26.6%) but its use has decreased since 2010. In the US, 48.8% of operators never use ultrasound and 92.6% of OUS operators never use it; only 4.4% overall use ultrasound in >50% of cases. Use of bivalirudin has decreased in the US and OUS. Nearly, 30% of operators do not assess for radial artery patency following hemostasis. US respondents used TRA less commonly for primary PCI for STEMI than their global counterparts.
Conclusions
There is wide variation in how TRA procedures are performed including relatively low rates of adherence to practices that are known to improve outcomes. Further education aimed at increasing use of best practices will impact patient outcomes.
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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.
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.
Background Bleeding has recently emerged as predictor of early and late mortality after percutaneous coronary intervention (PCI) using femoral approach. Transradial PCI is associated with a lower ...risk of access-site complications than femoral approach. We evaluated the predictors of bleeding and the impact of major bleeding on death and major adverse cardiac events (MACE) after transradial PCI and maximal antiplatelet therapy. Methods In the EASY (EArly discharge after transradial Stenting of coronarY arteries) trial, 1,348 patients with acute coronary syndrome were enrolled and underwent transradial PCI. All patients received clopidogrel (90% ≥12 hours pre-PCI) and a bolus of abciximab before first balloon inflation. Univariate and multivariate analyses to identify predictors and prognostic impact of major bleeding on death and MACE (death, myocardial infarction, and target vessel revascularization) were performed. Results From the study population, 19 (1.4%) patients presented major bleeding. Patients with bleeding were older, had lower creatinine clearance, more often had 3-vessel disease and ≥3 dilated sites, and had longer procedures. Independent predictors of bleeding were creatinine clearance <60 mL/min (odds ratio OR 3.26, 95% confidence interval CI 1.10-8.67, P = .022), procedure duration (OR 2.95, 95% CI 1.12-8.31, P = .032), and sheath size (OR 5.34, 95% CI 1.44-34.65, P = .029). In patients with major bleeding, the incidence of MACE was higher at 30 days (37% vs 3%), 6 months (42% vs 8%), and 12 months (53% vs 12%; P < .0001 for all comparisons). By multivariate analysis, major bleeding was an independent predictive factor of 1-year mortality and MACE. Conclusion After transradial PCI and maximal antiplatelet therapy, the incidence of major bleeding remains low. Major bleeding is an independent predictive factor of adverse acute and 1-year outcomes, regardless of the access site.
To review the technical limitations of available pressure-wires, present the design evolution of a nitinol fiber-optic pressure wire and to summarize the First-in-Man (FIM) O
pilot study results.
...Despite increasing use of physiology assessment of coronary lesions, several technical limitations persist. We present technical details, design evolution and early clinical results with a novel 0.014" nitinol fiber-optic based pressure-wire.
The 0.014' OptoWire™ (Opsens Medical, Quebec, Canada) was designed to combine improved handling properties compared to standard pressure-wires and to offer extremely reliable pressure recording and transmission due to fiber-optic properties compared to piezo-electric sensors and electrical wires. In vitro assessment showed that OptoWire™ steerability, pushability and torquability properties were closer to regular PCI wires than standard electrical pressure wires. In the First-in-Man O
study, 60 patients were recruited at 2 centers in Canada. A total of 103 lesions were assessed with the OptoWire™ and OptoMonitor™, 75 lesions at baseline and 28 lesions post-PCI (without disconnection). In all crossed lesions (n = 100, 97%), mean Pd/Pa and FFR could be adequately measured. In 11 cases assessed successively with OptoWire™ and Aegis™ (Abbott Vascular, USA) bland-Altman analysis showed a mean difference of 0.002 ± 0.052 mmHg (p = .91) for Pd/Pa and 0.01 ± 0.06 for FFR calculation (p = .45). There was no device-related complication. Upon these initial results, several design changes aimed to improve overall performance including torquability, stiffness, resistance to kink and pressure drift were completed.
The novel 0.014" fiber-optic OptoWire™ provides superior wire handling with reduced risk of pressure drift allowing reliable pre- and post-PCI physiology assessment.
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