Faculty Bibliography

AIMS/OBJECTIVE:The 6 Fr Glidesheath Slender (GSS6Fr) is a recently developed thin-walled radial sheath with an outer diameter (OD) that is smaller than the OD of standard 6 Fr sheaths. The purpose of this trial was to clarify whether the use of this new slender sheath would result in similar rates of RAO to a standard 5 Fr sheath in unselected patients undergoing transradial (TR) coronary angiography and/or intervention, and to assess the relative importance of sheath size and haemostasis protocol on the rate of RAO. METHODS AND RESULTS/RESULTS:We conducted a randomised, multicentre, non-inferiority trial comparing the GSS6Fr against the standard GS5Fr in patients undergoing TR coronary angiography and/or intervention. Patients in each group were subsequently randomised to undergo patent haemostasis or the institutional haemostasis protocol. The primary endpoint was the occurrence of RAO at discharge. A total of 1,926 patients were randomised in 12 centres. The incidence of RAO was 3.47% with GSS6Fr compared with 1.74% with GS5Fr (risk difference 1.73%, 95% CI: 0.51-2.95%; pnon-inferiority=0.150). Patients randomised to patent haemostasis had a similar rate of RAO compared with institutional haemostasis (2.61% vs. 2.61%, p=1). There was no difference with regard to all secondary endpoints, including vascular access-site complications, local bleeding and spasm. CONCLUSIONS:In this large multicentre randomised trial, the GSS6Fr was associated with a low event rate for the primary endpoint (RAO), although non-inferiority to the GS5Fr was not met, due to a lower than expected rate of RAO in the GS5Fr group. As compared to institutional haemostasis, the use of patent haemostasis was not associated with a reduced rate of RAO.

OBJECTIVE:To compare the efficacies of various post-percutaneous coronary intervenetion (PCI) bivalirudin doses on net adverse clinical events (NACEs) and mortality. BACKGROUND:In primary PCI, lower risk of bleeding with bivalirudin (vs. unfractionated heparin [UFH]) is counterbalanced by an increased risk of acute stent thrombosis (ST). Several randomized clinical trials (RCTs) and a recent meta-analysis suggest that acute ST risk may be eliminated without compromising the bleeding benefit, but only if the full dose, not a low dose, of bivalirudin is continued post-PCI. However, it is not known whether this improved risk leads to lower rates of NACEs and mortality. METHODS:Scientific databases and Web sites were searched for RCTs. Trials were included if study patients were undergoing primary PCI for acute ST-segment elevation myocardial infarction and were randomly assigned to bivalirudin or UFH treatment. The bivalirudin arm was divided based on post-PCI bivalirudin dosage: The Biv-Full group received 1.75 mg/kg/h, the Biv-Low group, 0.25 mg/kg/h, and the Biv-No group, none. RESULTS:Six RCTs involving 16,842 patients were found. In pairwise meta-analysis, bivalirudin improved 30-day all-cause mortality by 35% and cardiac mortality by 32%, but did not yield a NACE rate better than that achieved with UFH. Subgroup analysis showed the Biv-Full group had a 46% lower NACE rate and 47% lower all-cause mortality than UFH. These effects were not seen in the other two groups. Network meta-analysis yielded similar results. At treatment ranking, the Biv-Full group yielded the best treatment efficacy. CONCLUSIONS:In primary PCI, full-dose bivalirudin infusion for 3-4 hr after PCI appeared to improve NACE rates compared to UFH. It also seemed to be the most effective strategy for improving cardiac mortality and all-cause mortality. © 2016 Wiley Periodicals, Inc.

BACKGROUND:Morbidity and mortality conference is a common educational and quality improvement activity performed in cardiac catheterization laboratories, but best practices for case selection and for maximizing the effectiveness of peer review have not been determined. METHODS AND RESULTS/RESULTS:We reviewed the 10-year percutaneous coronary intervention morbidity and mortality conference experience of an academic medical center. Cases were triggered for review by the occurrence of prespecified procedural events. Summary reports from morbidity and mortality conference discussions were linked to clinical data from the Duke Databank for Cardiovascular Disease to compare baseline and procedural characteristics and to assess postdischarge outcomes. Of 11 786 procedures, from 2004 to 2013, 157 (1.3%) were triggered for review. The most frequent triggering events were cardioversion/defibrillation (72, 0.6%), unplanned use of mechanical circulatory support (64, 0.5%), and major dissection (41, 0.3%). Selected procedures were more likely to include high-risk features, such as ST-segment-elevation myocardial infarction, cardiogenic shock, and multivessel disease, and were associated with higher mortality at 30 days. Only a minority of triggering events were caused by controversial or unacceptable physician behavior. CONCLUSIONS:This 10-year experience outlines the processes for conduct of an effective percutaneous coronary intervention morbidity and mortality conference, including a novel approach to case selection and structured peer review leading to actionable quality interventions. The prespecified clinical triggers, captured in the natural workflow by laboratory staff, identified complex cases that were associated with poor patient outcomes.

BACKGROUND:Balancing risks and benefits of revascularization in elderly patients with multivessel coronary artery disease (CAD) is challenging. The appropriate revascularization strategy for elderly patients with multivessel CAD is unclear. METHODS:We used the Duke Databank for Cardiovascular Disease to identify patients aged 75 years or more who had multivessel disease and treatment with percutaneous coronary intervention or coronary artery bypass graft surgery (CABG) within 30 days of the index catheterization between October 1, 2003, and June 30, 2013. The primary outcome was a composite of all-cause death, myocardial infarction, and coronary revascularization through latest follow-up. Associations between bare-metal stents (BMS), drug-eluting stents (DES), CABG, and outcomes were determined using multivariable Cox proportional hazards modeling, adjusting for potential confounders with CABG as the reference. Comparisons between BMS and DES were done using BMS as the reference. RESULTS:We identified 763 patients who met the criteria (BMS, n = 202; DES, n = 411; CABG, n = 150). The median age was 79 years (interquartile range, 76 to 82), and the median follow-up was 6.28 years. After adjustment, both BMS and DES were associated with a higher risk of the primary outcome. The BMS versus CABG hazard ratio was 1.58 (95% confidence interval: 1.15 to 2.19, p = 0.01). The DES versus CABG hazard ratio was 1.45 (95% confidence interval: 1.08 to 1.95, p = 0.01). The adjusted hazard ratio for DES versus BMS (0.92, 95% confidence interval: 0.71 to 1.19, p = 0.51) was not statistically significant. CONCLUSIONS:In this single-center analysis of 763 elderly patients with multivessel disease, CABG was associated with the best overall clinical outcomes, but was selected for a minority of patients. An adequately powered, randomized trial should be considered to define the best treatment strategy for this population.

BACKGROUND:Professional guidelines have reduced the recommended minimum number to an average of 50 percutaneous coronary intervention (PCI) procedures performed annually by each operator. Operator volume patterns and associated outcomes since this change are unknown. OBJECTIVES/OBJECTIVE:The authors describe herein PCI operator procedure volumes; characteristics of low-, intermediate-, and high-volume operators; and the relationship between operator volume and clinical outcomes in a large, contemporary, nationwide sample. METHODS:Using data from the National Cardiovascular Data Registry collected between July 1, 2009, and March 31, 2015, we examined operator annual PCI volume. We divided operators into low- (<50 PCIs per year), intermediate- (50 to 100 PCIs per year), and high- (>100 PCIs per year) volume groups, and determined the adjusted association between annual PCI volume and in-hospital outcomes, including mortality. RESULTS:The median annual number of procedures performed per operator was 59; 44% of operators performed <50 PCI procedures per year. Low-volume operators more frequently performed emergency and primary PCI procedures and practiced at hospitals with lower annual PCI volumes. Unadjusted in-hospital mortality was 1.86% for low-volume operators, 1.73% for intermediate-volume operators, and 1.48% for high-volume operators. The adjusted risk of in-hospital mortality was higher for PCI procedures performed by low- and intermediate-volume operators compared with those performed by high-volume operators (adjusted odds ratio: 1.16 for low versus high; adjusted odds ratio: 1.05 for intermediate vs. high volume) as was the risk for new dialysis post PCI. No volume relationship was observed for post-PCI bleeding. CONCLUSIONS:Many PCI operators in the United States are performing fewer than the recommended number of PCI procedures annually. Although absolute risk differences are small and may be partially explained by unmeasured differences in case mix between operators, there remains an inverse relationship between PCI operator volume and in-hospital mortality that persisted in risk-adjusted analyses.

Few randomized controlled trials (RCTs) and observational studies had shown acceptable short-term efficacy and safety of percutaneous coronary intervention (PCI) with drug-eluting stents (DES) compared with coronary artery bypass grafting (CABG) in selected patients with left main coronary artery disease (LMCAD). We aimed to evaluate long-term outcomes of PCI using DES compared with CABG in patients with LMCAD. On November 1, 2016, we searched available databases for published RCTs directly comparing DES PCI with CABG in patients with LMCAD. Odds ratios (ORs) were used as the metric of choice for treatment effects using a random-effects model. I-squared index was used to assess heterogeneity across trials. Prespecified end points were all-cause mortality, cardiovascular mortality, myocardial infarction (MI), stroke, and repeat revascularization at maximal available follow-up. We identified 5 RCTs including a total of 4,595 patients, with a median follow-up of 60 months. The risk of all-cause mortality (OR 1.01; 95% confidence interval [CI] 0.76 to 1.34) and cardiovascular mortality (OR 1.02; 95% CI 0.73 to 1.42) were comparable between PCI with DES and CABG. Similarly, there were no statistically significant differences between PCI with DES and CABG for MI (OR 1.45; 95% CI 0.87 to 2.40) and stroke (OR 0.87; 95% CI 0.38 to 1.98). Conversely, repeat revascularization was significantly higher with PCI compared with CABG (OR 1.82; 95% CI 1.51 to 2.21). In conclusion, in patients with LMCAD, PCI with DES appears to be a viable alternative to CABG at long-term follow-up, with similar risks of ischemic adverse events (mortality, MI, and stroke) but a higher risk of repeat revascularization.

OBJECTIVES:The aim of this study was to compare bivalirudin with heparin as anticoagulant agents in patients with ST-segment elevation myocardial infarction treated with radial primary percutaneous coronary intervention (PCI). BACKGROUND:Recent studies in which PCI was performed predominantly via radial access did not show bivalirudin to be superior to heparin. METHODS:Outcomes were compared in patients with STEMI included in the National Cardiovascular Data Registry CathPCI database from 2009 to 2015 who underwent primary PCI via radial access and who were anticoagulated with bivalirudin or heparin. RESULTS:The sample included 67,368 patients, of whom 29,660 received bivalirudin and 37,708 received heparin. The 2 groups of patients did not differ significantly in their mean age or percentage of men. The unadjusted comparison showed no significant difference in the rate of the composite endpoint of death, myocardial infarction, or stroke (4.6% vs. 4.7%; p = 0.47) and a significantly higher rate of acute stent thrombosis (1.00% vs. 0.60%; p < 0.001) with bivalirudin compared with heparin. After adjusting for multiple variables, including a propensity score reflecting the probability of receiving bivalirudin, the odds ratio of the composite endpoint of death, myocardial infarction, or stroke for bivalirudin versus heparin was 0.95 (95% confidence interval: 0.87 to 1.05; p = 0.152), and the odds ratio for acute stent thrombosis was 2.11 (95% confidence interval: 1.73 to 2.57) for bivalirudin versus heparin. Major bleeding rates were not significantly different. CONCLUSIONS:In patients undergoing primary PCI via transradial access anticoagulated with bivalirudin or heparin, there was no difference in the composite endpoint of death, myocardial infarction, or stroke.

BACKGROUND:Transcatheter aortic valve replacement (TAVR) is a viable alternative to surgical aortic valve replacement (SAVR) in patients with severe aortic stenosis (SAS) who are at high risk for surgery. We sought to evaluate the outcomes of TAVR vs SAVR in low-intermediate risk patients with SAS. METHODS AND RESULTS/RESULTS:We performed random-effects meta-analysis of randomized controlled trials (RCTs) and propensity-matched observational studies comparing TAVR vs SAVR for low-intermediate risk patients. Five RCTs and 5 observational studies with a total of 6891 patients (3489 TAVR patients; 3402 SAVR patients) were included. Pooled data from RCTs showed no significant differences in all-cause mortality between TAVR and SAVR at 30 days (risk ratio [RR], 1.04; 95% confidence interval [CI], 0.73-1.47) and intermediate-term follow-up (RR, 0.86; 95% CI, 0.67-1.10). A trend toward decreased mortality was found with TAVR using the self-expandable vs balloon-expandable valves (RR, 0.77; 95% CI, 0.52-1.15 and RR, 1.91; 95% CI, 0.25-14.53, respectively) and transfemoral vs transthoracic approach (RR, 0.74; 95% CI, 0.55-1.01 and RR, 2.09; 95% CI, 0.40-11.03, respectively). Compared to SAVR, TAVR was associated with similar risks of stroke (RR, 0.91; 95% CI, 0.74-1.11) and myocardial infarction (RR, 1.00; 95% CI, 0.71-1.41). Furthermore, risks of major vascular complications, moderate-severe paravalvular regurgitation, and new permanent pacemaker implantation were higher with TAVR, whereas SAVR was associated with higher rates of acute kidney injury, atrial fibrillation, and major or life-threatening bleed. Finally, the above results from RCTs were consistent with pooled analyses of observational studies. CONCLUSION/CONCLUSIONS:TAVR appears to be a suitable alternative for patients with SAS who are at low-intermediate risk for SAVR.