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.
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.
Background:
In some randomized clinical trials, transradial access (TRA) compared with transfemoral access (TFA) was associated with lower mortality in patients with coronary artery disease ...undergoing invasive management. We analyzed the effects of TRA versus TFA across multicenter randomized clinical trials and whether these associations are modified by patient or procedural characteristics.
Methods:
We performed an individual patient data meta-analysis of multicenter randomized clinical trials comparing TRA with TFA among patients undergoing coronary angiography with or without percutaneous coronary intervention. The primary outcome was all-cause mortality and the co–primary outcome was major bleeding at 30 days. The primary analysis was conducted by 1-stage mixed-effects models on the basis of the intention-to-treat cohort. The effect of access site on mortality and major bleeding was assessed further by multivariable analysis. The relationship among access site, bleeding, and mortality was investigated by natural effect model mediation analysis with multivariable adjustment.
Results:
A total of 21 600 patients (10 775 TRA, 10 825 TFA) from 7 randomized clinical trials were included. The median age was 63.9 years, 31.9% were women, 95% presented with acute coronary syndrome, and 75.2% underwent percutaneous coronary intervention. All-cause mortality (1.6% versus 2.1%; hazard ratio, 0.77 95% CI, 0.63–0.95;
P
=0.012) and major bleeding (1.5% versus 2.7%; odds ratio, 0.55 95% CI, 0.45–0.67;
P
<0.001) were lower with TRA. Subgroup analyses for mortality showed consistent results, except for baseline hemoglobin level (
P
interaction
=0.003), indicating that the benefit of TRA was substantial in patients with moderate or severe anemia, whereas it was not significant in patients with milder or no baseline anemia. After adjustment, TRA remained associated with 24% and 51% relative risk reduction of all-cause mortality and major bleeding, respectively. A mediation analysis showed that the benefit of TRA on mortality was only partially driven by major bleeding prevention and ancillary mechanisms are required to fully explain the causal association.
Conclusions:
TRA is associated with lower all-cause mortality and major bleeding at 30 days compared with TFA. The effect on mortality was driven by patients with anemia. The reduction in major bleeding only partially explains the mortality benefit.
Registration:
URL:
https://www.crd.york.ac.uk/prospero
; Unique identifier: CRD42018109664.
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.
This study sought to compare radial and femoral approaches in patients presenting with ST-segment elevation myocardial infarction (STEMI) and undergoing primary percutaneous coronary intervention ...(PCI) by high-volume operators experienced in both access sites.
The exact clinical benefit of the radial compared to the femoral approach remains controversial.
STEMI-RADIAL (ST Elevation Myocardial Infarction treated by RADIAL or femoral approach) was a randomized, multicenter trial. A total of 707 patients referred for STEMI <12 h of symptom onset were randomized in 4 high-volume radial centers. The primary endpoint was the cumulative incidence of major bleeding and vascular access site complications at 30 days. The rate of net adverse clinical events (NACE) was defined as a composite of death, myocardial infarction, stroke, and major bleeding/vascular complications. Access site crossover, contrast volume, duration of intensive care stay, and death at 6 months were secondary endpoints.
The primary endpoint occurred in 1.4% of the radial group (n = 348) and 7.2% of the femoral group (n = 359; p = 0.0001). The NACE rate was 4.6% versus 11.0% (p = 0.0028), respectively. Crossover from radial to femoral approach was 3.7%. Intensive care stay (2.5 ± 1.7 days vs. 3.0 ± 2.9 days, p = 0.0038) as well as contrast utilization (170 ± 71 ml vs. 182 ± 60 ml, p = 0.01) were significantly reduced in the radial group. Mortality in the radial and femoral groups was 2.3% versus 3.1% (p = 0.64) at 30 days and 2.3% versus 3.6% (p = 0.31) at 6 months, respectively.
In patients with STEMI undergoing primary PCI by operators experienced in both access sites, the radial approach was associated with significantly lower incidence of major bleeding and access site complications and superior net clinical benefit. These findings support the use of the radial approach in primary PCI as first choice after proper training. (Trial Comparing Radial and Femoral Approach in Primary Percutaneous Coronary Intervention PCI STEMI-RADIAL; NCT01136187).
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).
...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.
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.
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.
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.
Patients with STEMI were assigned to primary PCI with or without thrombectomy. At 180 days, there was no significant between-group difference in the primary outcome of death or cardiovascular events. ...Patients in the thrombectomy group had a higher rate of stroke at 30 days.
Primary percutaneous coronary intervention (PCI), when available, is the most effective method of achieving reperfusion in patients with ST-segment elevation myocardial infarction (STEMI).
1
However, a major limitation of primary PCI is the possibility of distal embolization of thrombus and failure to restore flow at the microvascular level. Measures of microvascular tissue reperfusion, such as the degree of ST-segment resolution or angiographic myocardial blush grade, have been shown to predict the rate of death after primary PCI.
2
,
3
Removal of the thrombus by manual thrombectomy before stent deployment has the potential of reducing distal embolization and improving microvascular perfusion. Small, randomized . . .
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.
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.
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.
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