Faculty Bibliography

BACKGROUND:Routine thrombus aspiration in patients undergoing primary percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction (STEMI) does not improve clinical outcomes. However, there is remaining uncertainty about the potential benefit in those patients with high thrombus burden, where there is a biological rationale for greater benefit. OBJECTIVES:The purpose of this study was to evaluate the benefit of thrombus aspiration among STEMI patients with high thrombus burden. METHODS:TOTAL (ThrOmbecTomy with PCI vs. PCI ALone in patients with STEMI) was a randomized trial of routine manual thrombectomy versus PCI alone in patients with STEMI (n = 10,732). High thrombus burden (Thrombolysis In Myocardial Infarction thrombus grade ≥3) was a pre-specified subgroup. RESULTS:The primary outcome of cardiovascular (CV) death, MI, cardiogenic shock, or heart failure was not different at 1 year with thrombus aspiration in patients with high thrombus burden (8.1% vs. 8.3% thrombus aspiration; hazard ratio [HR]: 0.97; 95% confidence interval [CI]: 0.84 to 1.13) or low thrombus burden (6.0% vs. 5.0% thrombus aspiration; HR: 1.22; 95% CI: 0.73 to 2.05; interaction p = 0.41). However, among patients with high thrombus burden, stroke at 30 days was more frequent with thrombus aspiration (31 [0.7%] thrombus aspiration vs. 16 [0.4%] PCI alone, HR: 1.90; 95% CI: 1.04 to 3.48). In the high thrombus burden group, thrombus aspiration did not significantly improve CV mortality at 30 days (HR: 0.78; 95% CI: 0.61 to 1.01; p = 0.06) and at 1 year (HR: 0.88; 95% CI: 0.72 to 1.09; p = 0.25). Irrespective of treatment assignment, high thrombus burden was an independent predictor of death (HR: 1.78; 95% CI: 1.05 to 3.01). CONCLUSIONS:In patients with high thrombus burden, routine thrombus aspiration did not improve outcomes at 1 year and was associated with an increased rate of stroke. High thrombus burden is still an important predictor of outcome in STEMI. (A Trial of routine aspiration ThrOmbecTomy with PCI vs. PCI ALone in patients with STEMI [TOTAL]; NCT01149044).

Since the publication of the 2009 SCAI Expert Consensus Document on Length of Stay Following percutaneous coronary intervention (PCI), advances in vascular access techniques, stent technology, and antiplatelet pharmacology have facilitated changes in discharge patterns following PCI. Additional clinical studies have demonstrated the safety of early and same day discharge in selected patients with uncomplicated PCI, while reimbursement policies have discouraged unnecessary hospitalization. This consensus update: (1) clarifies clinical and reimbursement definitions of discharge strategies, (2) reviews the technological advances and literature supporting reduced hospitalization duration and risk assessment, and (3) describes changes to the consensus recommendations on length of stay following PCI (Supporting Information Table S1). These recommendations are intended to support reasonable clinical decision making regarding postprocedure length of stay for a broad spectrum of patients undergoing PCI, rather than prescribing a specific period of observation for individual patients.

BACKGROUND:The radial artery (RA) is routinely used for both hemodynamic monitoring and for cardiac catheterization. Although cannulation of the RA is usually undertaken through manual palpation, ultrasound (US)-guided access has been advocated as a mean to increase cannulation success rates and to lower RA complications; however, the published data are mixed. We sought to evaluate the impact of US-guided RA access compared with palpation alone on first-pass success to access RA. METHODS AND RESULTS:Meta-analysis of 12 randomized controlled trials comparing US-guided with palpation-guided radial access in 2,432 adult participants was done. Hemodynamic monitoring was the most common reason for RA catheterization. Only 2 randomized controlled trials evaluated patients undergoing cardiac catheterization. Ultrasound-guided radial access was associated with increased first-attempt success rate (risk ratio [RR] 1.35, 95% CI 1.16-1.57]) and decreased failure rate (RR 0.52, 95% CI 0.32-0.87). There were no significant differences in the risk of hematoma (RR 0.43, 95% CI 0.27-1.06), the mean time to first successful attempt (mean difference 25.13 seconds, 95% CI -1.06 to 51.34) or to any successful attempt (mean difference -4.74 seconds; 95% CI -22.67 to 13.18) between both groups. CONCLUSIONS:Ultrasound-guided technique for RA access has higher first-attempt success and lower failure rate compared with palpation alone, with no significant differences in access site hematoma or time to a successful attempt. These findings support the routine use of US guidance for RA access.

BACKGROUND:Studies with short-term follow-up found higher mortality in patients with STEMI who underwent primary PCI during off-hours as compared to regular working hours. We analyzed the interaction between one and two-year survival of patients with STEMI who underwent primary PCI during regular working hours and off-hours in a tertiary care academic teaching hospital. METHODS:A total of 1126 STEMI patients treated with primary PCI between 2008 and 2013 were analyzed. Two-years follow-up were available in 941 (83%) patients. Multivariable survival analysis was used to estimate the relationship between treatment during off-hours versus regular hours and the incidence of all-cause mortality at 2-years follow-up. Logistic regression was used to calculate interaction p-values between time of admission and time (between ≤1 year and ≤2 year). RESULTS:At 2-years, the mortality rate of patients admitted during off-hours and regular hours was similar (15% vs. 19%; adjusted hazard ratio 0.77; 95% confidence interval 0.52-1.16). Of the 941 patients, those who admitted during off-hours (N = 717) had similar median door-to-device time (94 min vs. 91 min), final Thrombolysis In Myocardial Infarction 3 flow grade (93% vs. 91%) and use of dual antiplatelet within 24 h (96% vs. 98% respectively) as compared with regular hours admission (N = 224). There were no mortality difference observed between one year and two years (p interaction >0.05). CONCLUSION:In this analysis, the similar mortality observed at one year between patients with STEMI treated by primary PCI during off-hour and regular hour were maintained at two years.

Patients with post-traumatic stress disorder (PTSD) are at risk of multiple co-morbidities and are more likely to develop incident heart failure with reduced ejection fraction (HFrEF). The relation of PTSD with clinical outcomes in HFrEF is not established. US veterans diagnosed with HFrEF from January 2007 to January 2015 and treated nationwide in the Veterans Affairs (VA) Health System were included in the study. Patients with HFrEF were identified through International Classification of Diseases, Ninth Revision (ICD-9) codes. Mortality data were obtained from the VA's death registry. We compared characteristics of patients with HFrEF with and without PTSD. We identified 111,970 VA patients with HFrEF and 11,039 patients with concomitant PTSD (9.9%). Patients with PTSD and HFrEF tended to be younger (64 vs 69 years) and have a higher rate of coronary artery disease (73% vs 64%), chronic obstructive pulmonary disease (42% vs 31%), and hypertension (80% vs 64%, p <0.01 for all variables). Patients with PTSD and HFrEF were more commonly on a high-dose β blocker (70% vs 68%, p <0.01) and angiotensin-converting enzyme inhibitors (96% vs 93%, p <0.01). PTSD was associated with significantly increased mortality at 7 years compared with patients with heart failure without PTSD (adjusted 1.54, 95% confidence interval 1.30 to 1.82, p <0.01). In conclusion, nearly 10% of veterans with HFrEF have PTSD. Patients with HFrEF with PTSD have a higher burden of co-morbidities, and PTSD is associated with a higher rate of all-cause death. Our findings support greater attention to the treatment of patients with PTSD and the causes associated with the poor outcomes.

It is unclear how age affects rates and causes of unplanned early readmissions after percutaneous coronary intervention (PCI). We analyzed patients in the Nationwide Readmission Database in the United States from 2010 to 2014 and examined the impact of age on readmissions after PCI. The primary outcomes were age-specific 30-day rates and causes of unplanned readmissions. A total of 2,294,345 procedures were analyzed with a 9.6% unplanned readmission rate within 30 days. Unplanned readmissions were 8.1%, 8.1%, 9.5%, and 12.6% for age groups <55, 55.0 to 64.9, 65.0-74.9, and ≥75 years, respectively. With increasing age, there was an increase in the rate of noncardiac causes for readmissions (for ages <55, 55.0 to 64.9, and ≥75 years, the rates were 54.1%, 54.8%, 56.6%, and 57.1%, respectively; p <0.001). Older age was associated with an increased prevalence of infections (13.9% ≥75 years vs 7.7% <55 years), gastrointestinal disease (11.5% ≥75 years vs 9.5% <55 years), and bleeding (7.4% ≥75 years vs 2.9% <55 years) as causes for noncardiac readmissions and a reduced prevalence of nonspecific chest pain (9.9% ≥75 years vs 31.4% <55 years). For cardiac causes, older age was associated with increased prevalence for readmissions due to heart failure (34.6% ≥75 years vs 11.9% <55 years) but a reduced prevalence of coronary artery disease, including angina (25.7% ≥75 years vs 51.3% <55 years). In conclusion, older patients have the highest rates of unplanned 30-day readmissions after PCI, with different causes for readmission compared with younger patients. Interventions designed to reduce readmissions after PCI should be age specific.

Robotic percutaneous coronary interventions have recently been introduced in the cardiac catheterization laboratory. Robotics offers benefits of greater precision for stent placement and occupational hazard protection for operators and staff. First generation systems were able to advance and retract coronary wires, balloons, and stents, but did not have guide control functions. The second-generation robotic system (CorPath GRX) has an active guide management function offering the ability to move guide catheters. Expanding utilization of robotics to perform diagnostic coronary angiography would further reduce radiation scatter exposure and other occupational hazards to operators. This approach is particularly appealing in the setting of radial access, as universal radial diagnostic catheters can engage both the right and left coronary arteries without exchange. We describe here, the first two cases of such a procedure with the CorPath GRX robotic system.

BACKGROUND:Several new trials evaluating transfusion strategies in patients with cardiovascular disease have recently been published, increasing the number of enrolled patients by over 30%. The objective was to evaluate transfusion thresholds in patients with cardiovascular disease. METHODS:We conducted an updated systematic review of randomized trials that compared patients assigned to maintain a lower (restrictive transfusion strategy) or higher (liberal transfusion strategy) hemoglobin concentration. We focused on new trial data in patients with cardiovascular disease. The primary outcome was 30-day mortality. Specific subgroups were patients undergoing cardiac surgery and with acute myocardial infarction. RESULTS:A total of 37 trials that enrolled 19,049 patients were appraised. In cardiac surgery, mortality at 30days was comparable between groups (risk ratio 0.99; 95% confidence interval 0.74-1.33). In 2 small trials (n=154) in patients with myocardial infarction, the point estimate for the mortality risk ratio was 3.88 (95% CI, 0.83-18.13) favoring the liberal strategy. Overall, from 26 trials enrolling 15,681 patients, 30-day mortality was not different between restrictive and liberal transfusion strategies (risk ratio 1.0, 95% CI, 0.86-1.16). Overall and in the cardiovascular disease subgroup, there were no significant differences observed across a range of secondary outcomes. CONCLUSIONS:New trials in patients undergoing cardiac surgery establish that a restrictive transfusion strategy of 7 to 8g/dL is safe and decreased red cell use by 24%. Further research is needed to define the optimal transfusion threshold in patients with acute myocardial infarction.

BACKGROUND:Few studies have examined the efficacy of drug-eluting stents (DES) for reducing aortocoronary saphenous vein bypass graft (SVG) failure compared with bare-metal stents (BMS) in patients undergoing stenting of de-novo SVG lesions. We assessed the risks and benefits of the use of DES versus BMS in de-novo SVG lesions. METHODS:Patients were recruited to our double-blind, randomised controlled trial from 25 US Department of Veterans Affairs centres. Eligible participants were aged at least 18 years and had at least one significant de-novo SVG lesion (50-99% stenosis of a 2·25-4·5 mm diameter SVG) requiring percutaneous coronary intervention with intent to use embolic protection devices. Enrolled patients were randomly assigned, in a 1:1 ratio, by phone randomisation system to receive a DES or BMS. Randomisation was stratified by presence or absence of diabetes and number of target SVG lesions requiring percutaneous coronary intervention (one or two or more) within each participating site by use of an adaptive scheme intended to balance the two stent type groups on marginal totals for the stratification factors. Patients, referring physicians, study coordinators, and outcome assessors were masked to group allocation. The primary endpoint was the 12-month incidence of target vessel failure, defined as the composite of cardiac death, target vessel myocardial infarction, or target vessel revascularisation. The DIVA trial is registered with ClinicalTrials.gov, number NCT01121224. FINDINGS:Between Jan 1, 2012, and Dec 31, 2015, 599 patients were randomly assigned to the stent groups, and the data for 597 patients were used. The patients' mean age was 68·6 (SD 7·6) years, and 595 (>99%) patients were men. The two stent groups were similar for most baseline characteristics. At 12 months, the incidence of target vessel failure was 17% (51 of 292) in the DES group versus 19% (58 of 305) in the BMS group (adjusted hazard ratio 0·92, 95% CI 0·63-1·34, p=0·70). Between-group differences in the components of the primary endpoint, serious adverse events, or stent thrombosis were not significant. Enrolment was stopped before the revised target sample size of 762 patients was reached. INTERPRETATION:In patients undergoing stenting of de-novo SVG lesions, no significant differences in outcomes between those receiving DES and BMS during 12 months of follow-up were found. The study results have important economic implications in countries with high DES prices such as the USA, because they suggest that the lower-cost BMS can be used in SVG lesions without compromising either safety or efficacy. FUNDING:US Department of Veterans Affairs Cooperative Studies Program.