Faculty Bibliography

BACKGROUND The long-term safety of paclitaxel-coated devices (PCDs; drug-coated balloon or drug-eluting stent) for peripheral endovascular intervention is uncertain. We used data from the Veterans Health Administration to evaluate the association between PCDs, long-term mortality, and cause of death. METHODS AND RESULTS Using the Veterans Administration Corporate Data Warehouse in conjunction with International Classification of Diseases, Tenth Revision (ICD-10) Procedure Coding System, Current Procedural Terminology, and Healthcare Common Procedure Coding System codes, we identified patients with peripheral artery disease treated within the Veterans Administration for femoropopliteal artery revascularization between October 1, 2015, and June 30, 2019. An adjusted Cox regression, using stabilized inverse probability-weighted estimates, was used to evaluate the association between PCDs and long-term survival. Cause of death data were obtained using the National Death Index. In total, 10 505 patients underwent femoropopliteal peripheral endovascular intervention; 2265 (21.6%) with a PCD and 8240 (78.4%) with a non-PCD (percutaneous angioplasty balloon and/or bare metal stent). Survival rates at 2 years (77.4% versus 79.7%) and 3 years (70.7% versus 71.8%) were similar between PCD and non-PCD groups, respectively. The adjusted hazard for all-cause mortality for patients treated with a PCD versus non-PCD was 1.06 (95% CI, 0.95-1.18, P=0.3013). Among patients who died between October 1, 2015, and December 31, 2017, the cause of death according to treatment group, PCD versus non-PCD, was similar. CONCLUSIONS Among patients undergoing femoropopliteal peripheral endovascular intervention within the Veterans Administration Health Administration, there was no increased risk of long-term, all-cause mortality associated with PCD use. Cause-specific mortality rates were similar between treatment groups.

Accurate evaluation of the quality of invasive cardiology procedures requires appraisal of case selection, technical performance, and procedural and clinical outcomes. Regrettably, the medical care delivery system poses a number of obstacles to developing and sustaining a high-quality environment. The purposes of this viewpoint are to summarize the most common impediments, followed to summarize the most common impediments, followed by the optimal ways to design and sustain a quality assurance program to overcome these barriers. A 7-step program to create and implement an effective quality assurance program is outlined.

OBJECTIVE:To describe from a non-interventional registry the short-term ischemic and hemorrhagic outcomes in patients with NSTEMI managed with a loading dose of a P2Y12 inhibitor (P2Y12i) given at least four hours prior to diagnostic angiography and delineation of coronary anatomy. Prior data on the effects of such "upstream loading" have been inconsistent. METHODS:In 53 US hospitals, we evaluated the in-hospital care and outcomes of patients with confirmed NSTEMI managed with an interventional strategy and loaded upstream (at least four hours before diagnostic angiography) with P2Y12 inhibitor therapy. Patients entered into the database were grouped into one of four cohorts for analysis: (1) overall cohort, (2) thienopyridine (clopidogrel or prasugrel) load, (3) ticagrelor load, and (4) ticagrelor-consistent. The fourth cohort is a subset of cohort 3 that received ticagrelor throughout the index hospital stay and at discharge. We evaluated in-hospital clinical course and ischemic and bleeding outcomes in all patients, and also 30-d outcomes in the ticagrelor-consistent cohort. RESULTS:A total of 3,355 patients were enrolled, of whom 1,087 had 30-day follow-up. The mean (+/-SD) age was 63.3+/-12.5 y and 62.6% were male. TIMI and GRACE scores placed these patients in the intermediate risk range and CRUSADE scores were in the moderate risk range. The loading dose in UPSTREAM was clopidogrel in 45.6%, ticagrelor in 53.6%, and prasugrel in 0.8%. The median upstream interval (loading dose to angiography) was 17:27 hours and did not change appreciably over the course of the data collection period (2/15 - 10/19). Access was radial in 48.6% and femoral in 51.4%. Post-angiography management was medical only in 32.3%, PCI in 59.4%, and CABG in 8.3%. Median LOS was 2.7d, and median time from angiography to CABG was 3.6d. In-hospital mortality was 0.51% and major bleeding (TIMI) was 0.24%; the in-hospital MACE rate was 0.7% and stent thrombosis occurred in 0.18%. No significant differences were seen between the ticagrelor and clopidogrel cohorts in hospital, but 16% received more than one P2Y12i in-hospital. On follow-up (93.2% response), 86.7% of patients reported taking ticagrelor as directed. CONCLUSION/CONCLUSIONS:Upstream loading of P2Y12 inhibitors was associated with very low rates of bleeding and short LOS in a large cohort of NSTEMI patients managed invasively.

Cardiogenic shock (CS) is a complex condition with a high risk for morbidity and mortality. Mechanical circulatory support (MCS) devices were developed to support patients with CS in cases refractory to treatment with vasoactive medications. Current devices include intra-aortic balloon pumps, intravascular microaxial pumps, percutaneous LVAD, percutaneous RVAD, and VA ECMO. Data from limited observational studies and clinical trials show a clear difference in the level of hemodynamic support offered by each device. However, at this point, there are insufficient clinical trial data to guide MCS selection and, until ongoing clinical trials are completed, use of the right device for the right patient depends largely on clinical judgment.

BACKGROUND:For low-risk patients with ST-elevation myocardial infarction (STEMI) undergoing percutaneous coronary intervention (PCI) the recommended optimal discharge timing is inconsistent in guidelines. The European Society of Cardiology guidelines recommend early discharge within 48-72 h, while the American College of Cardiology guidelines do not recommend a specific discharge strategy. In this systematic review and meta-analysis we compared outcomes with early discharge (≤3 days) versus late discharge (>3 days). METHODS:Randomized controlled trials (RCTs) and observational studies were selected after searching MEDLINE and EMBASE database. Meta-analysis was stratified according to study design. Outcomes were reported as random effects risk ratios (RR) with 95% confidence intervals. RESULTS:Seven RCTs comprising 1780 patients and 4 observational studies comprising 39,288 patients were selected. The RCT-restricted analysis did not demonstrate significant differences in terms of all-cause mortality (RR, 0.97 [0.23-4.05]) and major adverse cardiac events (MACE) (RR, 0.84 [0.56-1.26]). Conversely, observational study restricted analysis showed that early vs late discharge strategy was associated with a reduction in all-cause mortality (RR, 0.40 [0.23-0.71]) and MACE (RR, 0.45 [0.26-0.78]). There were no significant differences in hospital readmissions between early vs late discharge in both RCT or observational study analyses. CONCLUSIONS:Early discharge strategy in appropriately selected low-risk patients with STEMI undergoing PCI is safe and it has the potential to improve cost of care.

The society for cardiovascular angiography and interventions (SCAI) think tank is a collaborative venture that brings together interventional cardiologists, administrative partners, and select members of the cardiovascular industry community for high-level field-wide discussions. The 2020 think tank was organized into four parallel sessions reflective of the field of interventional cardiology: (a) coronary intervention, (b) endovascular medicine, (c) structural heart disease, and (d) congenital heart disease (CHD). Each session was moderated by a senior content expert and co-moderated by a member of SCAI's emerging leader mentorship program. This document presents the proceedings to the wider cardiovascular community in order to enhance participation in this discussion, create additional dialogue from a broader base, and thereby aid SCAI and the industry community in developing specific action items to move these areas forward.

OBJECTIVE:To evaluate the association of plasma long pentraxin 3 (PTX3) concentration with angiographic and clinical outcomes in patients with acute ST-segment elevation myocardial infarction (STEMI) treated by primary angioplasty. BACKGROUND:Whether concentration of PTX3, a sensitive marker of inflammation, associates with angiographic and clinical outcomes in STEMI patients treated by primary angioplasty is unknown. METHODS:We prospectively enrolled 335 consecutive patients with acute STEMI undergoing primary angioplasty. Blood samples for plasma PTX3 measurement were drawn in all patients at the emergency department before primary angioplasty, and were measured by ELISA method. RESULTS:The median PTX3 concentrations were higher in patients with thrombus burden grade 4 and 5 versus grade <4 on initial coronary angiogram (0.29 ng/ml vs. 0.24 ng/ml, p = .02), thrombolysis in myocardial infarction (TIMI) grade <3 vs. TIMI grade-3 flow after primary angioplasty (0.31 ng/ml vs. 0.24 ng/ml, p < .001), incomplete versus complete ST-segment resolution within 12 hr after angioplasty (0.29 ng/ml vs. 0.22 ng/ml, p = .001) and in patients who did not survive versus those who survived at 30 days (0.44 ng/ml vs. 0.26 ng/ml, p = .001). A linear correlation was observed between PTX3 concentration and baseline leukocyte count (Spearman correlation = 0.21, p < .001). After adjustment for laboratory and selected clinical variables, patients in the highest quartile of PTX3 concentration (≥0.4 ng/ml) were associated with increased risk of 30-day mortality (hazard ratio = 11.83; 95% confidence interval = 1.52-92.27, p = .01). CONCLUSION:This study suggests that higher plasma PTX3 concentration associates with worse angiographic and clinical outcomes in STEMI patients treated by primary angioplasty.