Faculty Bibliography

OBJECTIVES/OBJECTIVE:To assess feasibility and utility of imaging of both arms using ultrasound to facilitate transradial (TR) and transulnar (TU) coronary angiograms (CA) and intervention. BACKGROUND:Despite well recognized advantages, transradial approach (TRA) has challenges that reduce procedural success including small arterial size, anatomical variations, and anomalies of radial artery (RA). The utility of routine pre-procedural ultrasound of the arm arteries (PPUAA) in facilitating TRA has not been previously studied. METHODS:To determine the role of PPUAA, we performed a single center registry of consecutive patients undergoing diagnostic and interventional procedures between 2006 and 2011. All patients underwent PPUAA of the right and left radial, ulnar (UA), as well as the brachial arteries (BA) in the antecubital fossa using a linear probe. End-points assessed included the incidence and correlates of arterial sizes, vascular anomalies, procedure success, and fluoroscopy as well as ultrasound assessment times. RA occlusion rates were studied in the last 10 months of the study period. RESULTS:Complete data on radial (mean 1.9 mm (male);1.7 mm (female)) and ulnar artery size (mean 1.8 mm (male); 1.6 mm (female)) and data on brachial branching anatomy were available in 2,344 patients; 1,872 of whom underwent a TR or TU procedure. The mean time to perform bilateral PPUAA was 6.4 min ± 1.8 min. The incidence of arterial abnormalities was 9.8% in PPUAA. Procedure success was 98.7% for CA and 97.5% for percutaneous coronary intervention. Outcomes were better in this cohort compared with remaining 3,781 patients in whom PPUAA data were not available. CONCLUSION/CONCLUSIONS:This single center prospective registry shows that PPUAA is feasible, requires minimum time, and provides anatomical information that may improve procedure success while reducing patient discomfort, arterial spasm, and fluoroscopy time. These findings should be confirmed in a randomized trial.

OBJECTIVES/OBJECTIVE:The purpose of this study was to examine use and describe outcomes of radial access for percutaneous coronary intervention (PCI) in patients with ST-segment elevation myocardial infarction (STEMI). BACKGROUND:Transradial PCI (TRI) is associated with reduced risk of bleeding and vascular complications, as compared with femoral access PCI (FPCI). Studies have suggested that TRI may reduce mortality among patients with STEMI. METHODS:We examined 294,769 patients undergoing PCI for STEMI at 1,204 hospitals in the CathPCI Registry between 2007 and 2011. Patients were grouped according to access site used for PCI. The temporal trend in the rate of radial versus femoral approach was determined. For minimization of confounding, an inverse probability weighting analysis incorporating propensity scores was used to compare procedural success, post-PCI bleeding, door-to-balloon times, and in-hospital mortality between radial and femoral access. RESULTS:Over the 5-year period, the use of TRI versus FPCI in STEMI increased from 0.9% to 6.4% (p < 0.0001). There was no difference in procedural success. TRI was associated with longer median door-to-balloon time (78 vs. 74 min; p < 0.0001) but lower adjusted risk of bleeding (odds ratio [OR]: 0.62; 95% CI: 0.53 to 0.72; p < 0.0001) and lower adjusted risk of in-hospital mortality (OR: 0.76; 95% CI: 0.57 to 0.99; p = 0.0455). CONCLUSIONS:In this large national database, use of radial access for PCI in STEMI increased over the study period. Despite longer door-to-balloon times, the radial approach was associated with lower bleeding rate and reduced in-hospital mortality. These data provide support to execute an adequately powered randomized controlled trial comparing radial and femoral approaches for PCI in STEMI.

OBJECTIVES/OBJECTIVE: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.

In a meta-analysis of predominantly observational data, blood transfusion was independently associated with adverse outcomes in patients with myocardial infarction. These findings are consistent with previously published research, but clinical application of these data is hindered by the lack of prospective, randomized trials and the inherent bias in observational studies.

AIMS/OBJECTIVE:Data suggest that there is a variable use of thrombectomy during primary percutaneous coronary interventions (PPCI). We sought to evaluate practices during PPCI for ST-elevation myocardial infarction (STEMI), including the use of aspiration thrombectomy, and to determine the feasibility of conducting a definitive aspiration thrombectomy trial. METHODS AND RESULTS/RESULTS:A 27-item online survey was distributed to 1,607 interventional cardiologists internationally. A total of 461 responses were received. During PPCI, aspiration thrombectomy is used routinely by 36% of respondents, and selectively by 60%. Twenty-five percent of respondents reported experiencing a complication related to thrombectomy including: vessel dissection (13%), bringing thrombus back into left main coronary artery from target vessel (5%), stroke or transient ischaemic attack (2%), and coronary artery perforation (1%). The vast majority of respondents (89%) believe that a confirmatory aspiration thrombectomy trial is needed and 85% would be willing to randomise patients in such a trial. CONCLUSIONS:The majority of interventional cardiologists surveyed are not using thrombectomy routinely during PPCI. The survey results suggest that a large, confirmatory thrombectomy trial is needed and feasible in the current era. The survey also highlights a significant level of variability and underutilisation of other evidence-based therapies during PPCI.

Percutaneous coronary intervention (PCI) is an integral part of the treatment of coronary artery disease. The most common complication of PCI, bleeding, typically occurs at the vascular access site and is associated with short-term and long-term morbidity and mortality. Periprocedural bleeding also represents the primary safety concern of concomitant antithrombotic therapies essential for PCI success. Use of radial access for PCI reduces procedural bleeding and hence may change the risk profile and net clinical benefit of these drugs. This new drug-device safety interaction creates opportunities to advance the safe and effective use of antithrombotic agents during PCI. In June 2010 and March 2011, leaders from government, academia, professional societies, device manufacturing, and pharmaceutical industries convened for 2 think tank meetings. Titled TREAT I and II, these forums examined approaches to improve the overall safety of PCI by optimizing strategies for antithrombotic drug use and radial artery access. This article summarizes the content and proceedings of these sessions.

IMPORTANCE/OBJECTIVE:Bleeding is the most common complication after percutaneous coronary intervention (PCI) and is associated with increased morbidity and health care costs. The incidence of bleeding-related mortality after PCI has not been described in a nationally representative population. Furthermore, the relationships among bleeding risk, bleeding site, and mortality are unclear. OBJECTIVES/OBJECTIVE:To describe the association between bleeding events and in-hospital mortality after PCI and to estimate the adjusted population attributable risk (estimated as the proportion of mortality risk associated with bleeding events), risk difference, and number needed to harm (NNH) for bleeding-related in-hospital mortality after PCI. DESIGN, SETTING, AND PATIENTS/METHODS:Data from 3,386,688 procedures in the CathPCI Registry performed in the United States between 2004 and 2011 were analyzed. The population attributable risk was calculated after adjustment for baseline demographic, clinical, and procedural variables. To calculate the NNH for bleeding-related mortality, a propensity-matched analysis was performed. MAIN OUTCOME MEASURES/METHODS:In-hospital mortality. RESULTS:There were 57,246 bleeding events (1.7%) and 22,165 in-hospital deaths (0.65%) in 3,386,688 PCI procedures. The adjusted population attributable risk for mortality related to major bleeding was 12.1% (95% CI, 11.4%-12.7%) in the entire CathPCI cohort. The propensity-matched population consisted of 56,078 procedures with a major bleeding event and 224 312 controls. In this matched cohort, major bleeding was associated with increased in-hospital mortality (5.26% vs 1.87%; risk difference, 3.39% [95% CI, 3.20%-3.59%]; NNH = 29 [95% CI, 28-31]; P < .001). The association between major bleeding and in-hospital mortality was observed in all strata of preprocedural bleeding risk (low: 1.62% vs 0.17%; risk difference, 1.45% [95% CI, 1.13%-1.77%], NNH = 69 [95% CI, 57-88], P < .001; intermediate: 3.27% vs 0.71%; risk difference, 2.56% [95% CI, 2.33%-2.79%], NNH = 39 [95% CI, 36-43], P < .001; and high: 8.16% vs 3.45%; risk difference, 4.71% [95% CI, 4.35%-5.07%], NNH = 21 [95% CI, 20-23], P < .001). Although both access-site and non-access-site bleeding were associated with increased in-hospital mortality (2.73% vs 1.87%; risk difference, 0.86% [95% CI, 0.66%-1.05%], NNH = 117 [95% CI, 95-151], P < .001; and 8.25% vs 1.87%; risk difference, 6.39% [95% CI, 6.04%-6.73%], NNH = 16 [95% CI, 15-17], P < .001, respectively), the NNH was lower for nonaccess bleeding. CONCLUSIONS AND RELEVANCE/CONCLUSIONS:In a large registry of patients undergoing PCI, postprocedural bleeding events were associated with increased risk of in-hospital mortality, with an estimated 12.1% of deaths related to bleeding complications.

OBJECTIVES/OBJECTIVE:The authors sought to compare the radiation dose between radial and femoral access. BACKGROUND:Small trials have shown an increase in the radiation dose with radial compared with femoral access, but many were performed during the operators' learning curve of radial access. METHODS:Patients were randomized to radial or femoral access, as a part of the RIVAL (RadIal Vs. femorAL) trial (N = 7,021). Fluoroscopy time was prospectively collected in 5740 patients and radiation dose quantified as air kerma in 1,445 patients and dose-area product (DAP) in 2,255 patients. RESULTS:Median fluoroscopy time was higher with radial versus femoral access (9.3 vs. 8.0 min, p < 0.001). Median air kerma was nominally higher with radial versus femoral access (1,046 vs. 930 mGy, respectively, p = 0.051). Median DAP was not different between radial and femoral access (52.8 Gy-cm(2) vs. 51.2 Gy·cm(2), p = 0.83). When results are stratified according to procedural volume, air kerma was increased only in the lowest tertile of radial volume centers (low 1,425 vs. 1,045 mGy, p = 0.002; middle 987 vs. 958 mGy, p = 0.597; high 652 vs. 621 mGy, p = 0.403, interaction p = 0.026). Multivariable regression showed procedural volume was the greatest independent predictor of lower air kerma dose (ratio of geometric means 0.55; 95% confidence interval 0.49 to 0.61 for highest-volume radial centers). CONCLUSIONS:Radiation dose as measured by air kerma was nominally higher with radial versus femoral access, but differences were present only in lower-volume centers and operators. High-volume centers have the lowest radiation dose irrespective of which access site approach that they use. (A Trial of Trans-radial Versus Trans-femoral Percutaneous Coronary Intervention (PCI) Access Site Approach in Patients With Unstable Angina or Myocardial Infarction Managed With an Invasive Strategy [RIVAL]; NCT01014273).

OBJECTIVES/OBJECTIVE:This study sought to compared the use and effectiveness of bleeding avoidance strategies (BAS) by sex. BACKGROUND:Women have higher rates of bleeding following percutaneous coronary intervention (PCI). METHODS:Among 570,777 men (67.5%) and women (32.5%) who underwent PCI in the National Cardiovascular Data Registry's CathPCI Registry between July 1, 2009 and March 31, 2011, in-hospital bleeding rates and the use of BAS (vascular closure devices, bivalirudin, radial approach, and their combinations) were assessed. The relative risk of bleeding for each BAS compared with no BAS was determined in women and men using multivariable logistic regressions adjusted for clinical characteristics and the propensity for receiving BAS. Finally, the absolute risk differences in bleeding associated with BAS were compared. RESULTS:Overall, the use of any BAS differed slightly between women and men (75.4% vs. 75.7%, p = 0.01). When BAS was not used, women had significantly higher rates of bleeding than men (12.5% vs. 6.2%, p < 0.01). Both sexes had similar adjusted risk reductions of bleeding when any BAS was used (women, odds ratio: 0.60, 95% confidence interval [CI]: 0.57 to 0.63; men, odds ratio: 0.62, 95% CI: 0.59 to 0.65). Women and men had lower absolute bleeding risks with BAS; however, these absolute risk differences were greater in women (6.3% vs. 3.2%, p < 0.01). CONCLUSIONS:Women continue to have almost twice the rate of bleeding following PCI. The use of any BAS was associated with a similarly lower risk of bleeding for men and women; however, the absolute risk differences were substantially higher in women. These data underscore the importance of applying effective strategies to limit post-PCI bleeding, especially in women.