Faculty Bibliography

BACKGROUND:Transradial percutaneous coronary intervention (PCI [TRI]) does not involve catheter manipulation in the descending aorta, whereas transfemoral PCI (TFI) does. Therefore, the risk of acute kidney injury (AKI) after PCI might be influenced by vascular access site. We compared risks of AKI and nephropathy requiring dialysis (NRD) among patients treated with TRI and TFI. METHODS AND RESULTS/RESULTS:We included patients across 47 hospitals in Michigan. Primary end point was AKI (serum creatinine increase ≥0.5 mg/dL). Secondary end points were NRD and postprocedural bleeding. Odds ratios (OR) for study end points were calculated for the entire and propensity-matched population, reported as crude, and values adjusted for preprocedural calculated AKI risk. Between 2010 and 2012, a total of 82 225 PCI procedures were performed, of which 8915 were TRI. After adjustment, TRI was associated with a reduction in AKI (OR, 0.76, 95% confidence intervals [0.62-0.92]) and bleeding with a trend toward lower NRD risk. The propensity-matched population consisted of 8857 procedures per group. In this population, TRI was associated with lower adjusted odds of AKI (OR, 0.74; 95% confidence intervals [0.58-0.96]), and bleeding (OR, 0.47; 95% confidence intervals [0.36-0.63]), but no difference in NRD was observed. Although postprocedural bleeding was independently associated with AKI (OR, 2.86; 95% confidence intervals [1.75-4.66]) in the propensity-matched population, the lower odds of AKI was not mediated by a reduction in bleeding with TRI. Sensitivity analysis demonstrated that the observed association between access site and AKI could potentially be explained by a moderately strong unknown confounder. CONCLUSIONS:The risk of AKI was significantly lower after TRI compared with TFI. This finding needs to be evaluated in randomized controlled trials.

IMPORTANCE/OBJECTIVE:Studies have shown variation in the use of red blood cell transfusion among patients with acute coronary syndromes. There are no definitive data for the efficacy of transfusion in improving outcomes, and concerning data exist about possible association with harm. Current transfusion practices in patients undergoing percutaneous coronary intervention (PCI) are not well understood. OBJECTIVE:To determine the current patterns of blood transfusion among patients undergoing PCI and the association of transfusion with adverse cardiac outcomes across hospitals in the United States. DESIGN, SETTING, AND PARTICIPANTS/METHODS:Retrospective cohort study of all patient visits from the CathPCI Registry from July 2009 to March 2013 that included PCI, excluding those with missing data on bleeding complications or who underwent in-hospital coronary artery bypass graft surgery (N = 2,258,711 visits). MAIN OUTCOMES AND MEASURES/METHODS:Transfusion rates in the overall population and by hospital (N = 1431) were the primary outcomes. The association of transfusion with myocardial infarction, stroke, and death after accounting for a patient's propensity for transfusion was also measured. RESULTS:The overall rate of transfusion was 2.14% (95% CI, 2.13%-2.16%) and quarterly transfusion rates slightly declined from July 2009 to March 2013 (from 2.11% [95% CI, 2.03%-2.19%] to 2.04% [95% CI, 1.97%-2.12%]; P < .001). Patients who were more likely to receive transfusion were older (mean, 70.5 vs 64.6 years), were women (56.3% vs 32.5%), and had hypertension (86.4% vs 82.0%), diabetes (44.8% vs 34.6%), advanced renal dysfunction (8.7% vs 2.3%), prior myocardial infarction (33.0% vs 30.2%), or prior heart failure (27.0% vs 11.8%). Overall, 96.3% of sites gave a transfusion to less than 5% of patients and 3.7% of sites gave a transfusion to 5% of patients or more. Variation in hospital risk-standardized rates of transfusion persisted after adjustment, and hospitals showed variability in their transfusion thresholds. Receipt of transfusion was associated with myocardial infarction (42,803 events; 4.5% vs 1.8%; odds ratio [OR], 2.60; 95% CI, 2.57-2.63), stroke (5011 events; 2.0% vs 0.2%; OR, 7.72; 95% CI, 7.47-7.98), and in-hospital death (31,885 events; 12.5% vs 1.2%; OR, 4.63; 95% CI, 4.57-4.69), irrespective of bleeding complications. CONCLUSIONS AND RELEVANCE/CONCLUSIONS:Among patients undergoing PCI at US hospitals, there was considerable variation in blood transfusion practices, and receipt of transfusion was associated with increased risk of in-hospital adverse cardiac events. These observational findings may warrant a randomized trial of transfusion strategies for patients undergoing PCI.

BACKGROUND:A major limitation of primary percutaneous coronary intervention (PPCI) for the treatment of ST-elevation myocardial infarction (STEMI) is impaired microvascular perfusion due to embolization and obstruction of microcirculation with thrombus. Manual thrombectomy has the potential to reduce distal embolization and improve microvascular perfusion. Clinical trials have shown mixed results regarding thrombectomy. OBJECTIVE:The objective of this study is to evaluate the efficacy of routine upfront manual aspiration thrombectomy during PPCI compared with percutaneous coronary intervention alone in patients with STEMI. DESIGN/METHODS:This is a multicenter, prospective, open, international, randomized trial with blinded assessment of outcomes. Patients with STEMI undergoing PPCI are randomized to upfront routine manual aspiration thrombectomy with the Export catheter (Medtronic CardioVascular, Santa Rosa, CA) or to percutaneous coronary intervention alone. The primary outcome is the composite of cardiovascular death, recurrent myocardial infarction, cardiogenic shock, or new or worsening New York Heart Association class IV heart failure up to 180 days. The trial uses an event-driven design and will recruit 10,700 patients. SUMMARY/CONCLUSIONS:The TOTAL trial will determine the effect of routine manual aspiration thrombectomy during PPCI on clinically important outcomes.

BACKGROUND:The contemporary need for repeat revascularization in older patients after percutaneous coronary intervention (PCI) has not been well studied. Understanding repeat revascularization risk in this population may inform treatment decisions. METHODS:We analyzed patients ≥65 years old undergoing native-vessel PCI of de novo lesions from 2005 to 2009 discharged alive using linked CathPCI Registry and Medicare data. Repeat PCIs within 1 year of index procedure were identified by claims data and linked back to CathPCI Registry to identify target vessel revascularization (TVR). Surgical revascularization and PCIs not back linked to CathPCI Registry were excluded from main analyses but included in sensitivity analyses. Independent predictors of TVR after drug-eluting stent (DES) or bare-metal stent (BMS) implantation were identified by multivariable logistic regression. RESULTS:Among 343,173 PCI procedures, DES was used in 76.5% (n = 262,496). One-year TVR ranged from 3.3% (overall) to 7.1% (sensitivity analysis). Precatheterization and additional procedure-related TVR risk models were developed in BMS (c-indices 0.54, 0.60) and DES (c-indices 0.57, 0.60) populations. Models were well calibrated and performed similarly in important patient subgroups (female, diabetic, and older [≥75 years]). The use of DES reduced predicted TVR rates in high-risk older patients by 35.5% relative to BMS (from 6.2% to 4.0%). Among low-risk patients, the number needed to treat with DES to prevent 1 TVR was 63-112; among high-risk patients, this dropped to 28-46. CONCLUSIONS:In contemporary clinical practice, native-vessel TVR among older patients occurs infrequently. Our prediction model identifies patients at low versus high TVR risk and may inform clinical decision making.

BACKGROUND:Hybrid coronary revascularization (HCR) represents a minimally invasive revascularization strategy in which the durability of the internal mammary artery to left anterior descending artery graft is combined with percutaneous coronary intervention to treat remaining lesions. We performed a systematic review and meta-analysis to compare clinical outcomes after HCR with conventional coronary artery bypass graft (CABG) surgery. METHODS:A comprehensive EMBASE and PUBMED search was performed for comparative studies evaluating in-hospital and 1-year death, myocardial infarction (MI), stroke, and repeat revascularization. RESULTS:Six observational studies (1 case control, 5 propensity adjusted) comprising 1,190 patients were included; 366 (30.8%) patients underwent HCR (185 staged and 181 concurrent), and 824 (69.2%) were treated with CABG (786 off-pump, 38 on-pump). Drug-eluting stents were used in 328 (89.6%) patients undergoing HCR. Hybrid coronary revascularization was associated with lower in-hospital need for blood transfusions, shorter length of stay, and faster return to work. No significant differences were found for the composite of death, MI, stroke, or repeat revascularization during hospitalization (odds ratio 0.63, 95% CI 0.25-1.58, P = .33) and at 1-year follow-up (odds ratio 0.49, 95% CI 0.20-1.24, P = .13). Comparisons of individual components showed no difference in all-cause mortality, MI, or stroke, but higher repeat revascularization among patients treated with HCR. CONCLUSIONS:Hybrid coronary revascularization is associated with lower morbidity and similar in-hospital and 1-year major adverse cerebrovascular or cardiac events rates, but greater requirement for repeat revascularization compared with CABG. Further exploration of this strategy with adequately powered randomized trials is warranted.

Major bleeding complications after percutaneous coronary intervention (PCI) increase patient morbidity, prolong the hospital stay and costs, and are associated with reduced survival. Transfemoral access is still preferred at many centers given its familiarity and ease of use and is necessary in cases where large bore access is needed. Multimodality imaging with fluoroscopy, ultrasonography, and angiography can facilitate proper puncture of the common femoral artery. A proper technique (which includes femoral artery puncture and vascular access site closure) associated with adequate pharmacotherapy (both during PCI and peri-procedural, for the treatment of the underlying coronary artery disease) has been shown to reduce the risk of bleeding and vascular complications associated with femoral artery access. Avoiding the use of arterial sheaths >6 French may further reduce the risk of bleeding. Data with vascular closure devices as a bleeding avoidance strategy are evolving but when used appropriately may further reduce the risk of bleeding and vascular access complications, and in this regard are synergistic with bivalirudin. Randomized trials to confirm these recommendations are needed.

OPINION STATEMENT/UNASSIGNED:Bleeding events are the most common complications following percutaneous coronary intervention (PCI) and are associated with increases in short- and long-term mortality, nonfatal myocardial infarction, stroke, hospital length of stay, and hospital cost. Over time, there has been a decrease in periprocedural bleeding, primarily due to improvements in antithrombotic therapy; however, transradial (TR) catheterization has been shown to be an important strategy to minimize access site bleeding and potentially improve outcomes among patients with ST-segment elevation myocardial infarction. The rate of TR catheterization has been increasing significantly over the past few years and now accounts for an increasing proportion of procedures performed in the United States. Results from the recently published RIVAL Trial have shown comparable efficacy between transradial and transfemoral (TF) approaches with significant reduction in vascular access complications in the TR group. TR access in the STEMI population was prospectively assessed in the RIFLE-STEACS Trial and demonstrated significant reduction in the primary outcome of composite death/MI/stroke/target vessel revascularization/non-CABG bleeding. More recent studies have also demonstrated cost savings with TR access, related primarily to decreased hospital length of stay. While previous studies have shown increased operator radiation exposure compared to a TF approach, the most recent data suggest no significant difference in radiation at higher volume centers.

BACKGROUND:Adoption of transradial percutaneous coronary intervention (TRI) in the United States is low and may be related to challenges learning the technique. We examined the relationships between operator TRI volume and procedural metrics and outcomes. METHODS AND RESULTS/RESULTS:We used CathPCI Registry data from July 2009 to December 2012 to identify new radial operators, defined by an exclusively femoral percutaneous coronary intervention approach for 6 months after their first percutaneous coronary intervention in the database and ≥15 total TRIs thereafter. Primary outcomes of fluoroscopy time, contrast volume, and procedure success were chosen as markers of technical proficiency. Secondary outcomes included in-hospital mortality, bleeding, and vascular complications. Adjusted outcomes were analyzed by using operator TRI experience as a continuous variable with generalized linear mixed models. Among 54 561 TRI procedures performed at 704 sites, 942 operators performed 1 to 10 procedures, 942 operators performed 11 to 50 procedures, 375 operators performed 51 to 100 procedures, and 148 operators performed 101 to 200 procedures. As radial caseload increased, more TRIs were performed in women, in patients presenting with ST-segment elevation myocardial infarction, and for emergency indications. Decreased fluoroscopy time and contrast use were nonlinearly associated with greater operator TRI experience, with faster reductions observed for newer (<30-50 cases) compared with more experienced (>30-50 cases) operators. Procedure success was high, whereas mortality, bleeding, and vascular complications remained low across TRI volumes. CONCLUSIONS:As operator TRI volume increases, higher-risk patients are chosen for TRI. Despite this, operator proficiency improves with greater TRI experience, and safety is maintained. The threshold to overcome the learning curve appears to be approximately 30 to 50 cases.

BACKGROUND:Whether increasing use of radial access has improved percutaneous coronary intervention outcomes remains unknown. We sought to determine the relationship between increasing facility-level use of transradial percutaneous coronary intervention (TRI) and periprocedural outcomes. METHODS AND RESULTS/RESULTS:Within the National Cardiovascular Data Registry CathPCI Registry, we estimated the risk-adjusted association between hospital category of change in TRI use (during the 3-year period from 2009 to 2012) and trends in access site and overall bleeding, fluoroscopy time, and contrast use among 818 facilities with low baseline TRI use. There were 4 categories of hospital change in TRI use: very low (baseline, 0.2% increasing to 1.8% at the end of 3 years), low (0.9% increasing to 8.9%), moderate (1.6% increasing to 27.2%), and high (1.0% increasing to 45.1%). Risk-adjusted access site bleeding decreased over time for all hospital categories; however, the rate of decline varied across hospital categories (P for interaction, <0.001). The decrease in access site bleeding was significantly greater for hospitals with moderate or high increases in TRI use (relative risk, 0.45, 95% confidence interval, 0.36-0.56) when compared with that of very low or low hospitals (relative risk, 0.65; 95% confidence interval, 0.58-0.74; P for comparison, 0.002). Similar findings were observed for overall bleeding. An increase in fluoroscopy time (≈1.3 minutes) was noted at hospitals with moderate and high use of TRI (P=0.01). Trends in contrast use were similar across hospital categories. CONCLUSIONS:In a national sample of hospitals performing percutaneous coronary intervention, bleeding rates decreased over time for all hospital categories of change in TRI use. The decline in bleeding outcomes was larger at hospitals with increased adoption of TRI when compared with hospitals with minimal or no change in TRI use.