Aims
We aimed to evaluate the feasibility and safety of carotid artery stenting (CAS) with a newly designed double‐layer micromesh stent using wrist approach in patients with significant carotid ...disease.
Materials and Methods
Between January 2016 and December 2021, 105 patients undergoing CAS with Roadsaver™ stent were enrolled in a single center prospective study. Follow‐up assessments included neurological exams, duplex ultrasound (DUS), and 12‐lead ECG. The primary endpoint was the 30‐day composite rate of stroke, death, and myocardial infarction. Secondary endpoints included procedure success, access site complications, device success, target lesion revascularization, and in‐stent restenosis evaluated with DUS. Long‐term outcomes up to 72 months of follow‐up were assessed in all eligible patients.
Results
The study population was predominantly male (69.5%) with a median age of 68 ± 8 years. Patients were symptomatic in 80% of the cases, and 35% fulfilled the high‐risk criteria for surgical endarterectomy. The right internal carotid artery was the target artery in 56 (53.4%), and the left in 49 (46.6%) of the cases. All procedures were successfully completed from the right wrist, with right radial access in 94 (89.5%) cases and ulnar artery access with previous radial artery occlusion in 11 (10.5%) cases. All patients were treated successfully with the study device. The primary endpoint was met with a 30‐day major adverse event rate of 0.9% (1/105). Up to 72 months of follow‐up (median 30 ± 20 months) there were no strokes, neurological deaths, or target lesion revascularization of the treated lesion. Doppler ultrasound examination revealed nonsignificant in‐stent restenosis in two asymptomatic patients. There was no hand ischemia detected in any patient.
Conclusion
Results from this study demonstrate the radial and ulnar access for CAS with double layer micromesh Roadsaver™ stent is safe and feasible and associated with favorable early and long‐term follow‐up.
Objectives This study sought to: 1) determine the incidence, degree, and timing of the rise in serum cardiac markers of myocardial injury associated with uncomplicated transcatheter aortic valve ...implantation (TAVI); and 2) evaluate the predictive factors and prognostic value of myocardial injury associated with TAVI. Background Very few data exist on the occurrence and clinical relevance of myocardial injury during TAVI procedures. Methods A total of 101 patients who underwent successful TAVI (transfemoral TF approach, n = 38; transapical TA approach, n = 63) were included. Creatine kinase-MB (CK-MB) and cardiac troponin T (cTnT) levels were determined at baseline and at 6 to 12, 24, 48, and 72 h following TAVI. Results TAVI was associated with some degree of myocardial injury in 99% of the patients (TF: 97%, TA: 100%) as determined by a rise in cTnT (maximal value, 0.48 μg/l, interquartile range IQR: 0.24 to 0.82 μg/l) and in 77% of the patients (TF: 47%, TA: 95%) as determined by a rise in CK-MB (maximal value, 18.6 μg/l; IQR: 11.0 to 27.4 μg/l). TA approach and baseline renal dysfunction were associated with a higher increase in biomarkers of myocardial injury (p < 0.01 for both). A larger myocardial injury was associated with a smaller improvement of left ventricular ejection fraction (LVEF) (p < 0.01). The degree of rise in cTnT was an independent predictor of cardiac mortality at 9 ± 10 months of follow-up (hazard ratio: 1.14 per each increase of 0.1 μg/l, 95% confidence interval: 1.02 to 1.28, p = 0.028). Conclusions TAVI was systematically associated with some degree of myocardial injury, with TA approach and baseline renal dysfunction determining a higher increase in biomarkers of myocardial injury. A greater degree of myocardial injury was associated with less improvement in LVEF and a higher cardiac mortality at follow-up.
During primary percutaneous coronary intervention (PCI), manual thrombectomy may reduce distal embolization and thus improve microvascular perfusion. Small trials have suggested that thrombectomy ...improves surrogate and clinical outcomes, but a larger trial has reported conflicting results.
We randomly assigned 10,732 patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary PCI to a strategy of routine upfront manual thrombectomy versus PCI alone. The primary outcome was a composite of death from cardiovascular causes, recurrent myocardial infarction, cardiogenic shock, or New York Heart Association (NYHA) class IV heart failure within 180 days. The key safety outcome was stroke within 30 days.
The primary outcome occurred in 347 of 5033 patients (6.9%) in the thrombectomy group versus 351 of 5030 patients (7.0%) in the PCI-alone group (hazard ratio in the thrombectomy group, 0.99; 95% confidence interval CI, 0.85 to 1.15; P=0.86). The rates of cardiovascular death (3.1% with thrombectomy vs. 3.5% with PCI alone; hazard ratio, 0.90; 95% CI, 0.73 to 1.12; P=0.34) and the primary outcome plus stent thrombosis or target-vessel revascularization (9.9% vs. 9.8%; hazard ratio, 1.00; 95% CI, 0.89 to 1.14; P=0.95) were also similar. Stroke within 30 days occurred in 33 patients (0.7%) in the thrombectomy group versus 16 patients (0.3%) in the PCI-alone group (hazard ratio, 2.06; 95% CI, 1.13 to 3.75; P=0.02).
In patients with STEMI who were undergoing primary PCI, routine manual thrombectomy, as compared with PCI alone, did not reduce the risk of cardiovascular death, recurrent myocardial infarction, cardiogenic shock, or NYHA class IV heart failure within 180 days but was associated with an increased rate of stroke within 30 days. (Funded by Medtronic and the Canadian Institutes of Health Research; TOTAL ClinicalTrials.gov number, NCT01149044.).
Abstract Anemia is common amongst patients undergoing percutaneous coronary intervention (PCI) and current guidelines fail to offer recommendations for its management. This review aims to examine the ...relationship between baseline anemia and mortality, Major Adverse Cardiovascular Events (MACE) and major bleeding in patients undergoing PCI. We searched MEDLINE and EMBASE for studies that evaluated mortality and adverse outcomes in anemic and non-anemic patients who underwent PCI. Data were collected on study design, participant characteristics, definition of anemia, follow up and adverse outcomes. Random effects meta-analysis of risk ratios was performed using inverse variance method. A total of 44 studies were included in the review with 230,795 participants. The prevalence of baseline anemia was 26,514/170,914 (16%). There was an elevated risk of mortality and MACE with anemia compared to no anemia pooled RR 2.39 (2.02-2.83), p<0.001 and RR 1.51 (1.34-1.71), p<0.001, respectively. The risk of myocardial infarction and bleeding with anemia compared to no anemia was elevated, pooled RR 1.33 (1.07-1.65), p=0.01 and RR 1.97 (1.03-3.77), p<0.001, respectively. The risk of mortality per unit incremental decrease in hemoglobin(g/dl) was RR 1.19 (1.09-1.30), p<0.001 and the risk of mortality, MACE and re-infarction per 1 unit incremental decrease in hematocrit(%) was RR 1.07 (1.05-1.10), p=0.04, RR 1.09 (1.08-1.10) and RR 1.06 (1.03-1.10), respectively. The prevalence of anemia in contemporary cohorts of patients undergoing PCI is significant and is associated with significant increases in post procedural mortality, MACE, re-infarction and bleeding. The optimal strategy for the management of anemia in such patients remains uncertain.
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.
Background
Incidence of radial artery occclusions (RAO) and ulnar artery occclusions (UAO) in coronary procedures, factors predisposing to forearm arteries occlusion, and the benefit of ...anticoaggulation vary significantly in existing literature. We sought to determine the incidence of RAO/UAO and the impact of anticoagulation intensity.
Methods and Results
Meta‐analysis of 112 studies assessing RAO and/or UAO (N=46 631) were included. Overall, there was no difference between crude RAO and UAO rates (5.2%; 95% confidence interval CI, 4.4–6.0 versus 4.0%; 95% CI, 2.8–5.8; P=0.171). The early occlusion rate (in‐hospital or within 7 days after procedure) was higher than the late occlusion rate. The detection rate of occlusion was higher with vascular ultrasonography compared with clinical evaluation only. Low‐dose heparin was associated with a significantly higher RAO rate compared with high‐dose heparin (7.2%; 95% CI, 5.5–9.4 versus 4.3%; 95% CI, 3.5–5.3; Q=8.81; P=0.003). Early occlusions in low‐dose heparin cohorts mounted at 8.0% (95% CI, 6.1–10.6). The RAO rate was higher after diagnostic angiographies compared with coronary interventions, presumably attributed to the higher intensity of anticoagulation in the latter group. Hemostatic techniques (patent versus nonpatent hemostasis), geography (US versus non‐US cohorts) and sheath size did not impact on vessel patency.
Conclusions
RAO and UAO occur with similar frequency and in the order of 7% to 8% when evaluated early by vascular ultrasonography following coronary procedures. More‐intensive anticoagulation is protective. Late recanalization occurs in a substantial minority of patients.
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.
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