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Cardiogenic shock (CS) is the final common pathway of impaired cardiovascular performance that results in ineffective forward cardiac output producing clinical and biochemical signs of organ hypoperfusion. CS represents the most common cause of shock in the cardiac intensive care unit (CICU) and accounts for a substantial proportion of CICU patient deaths. Despite significant advances in revascularization techniques, pharmacologic therapeutics and mechanical support devices, CS remains associated with a high mortality rate. Indeed, the prevalence of CS within the CICU appears to be increasing. CS can be differentiated as phenotypes reflecting different metabolic, inflammatory, and hemodynamic profiles, depending also on anatomic substrate and congestion profile. Future prospective studies and clinical trials may further characterize these phenotypes and apply targeted intervention for each phenotype and SCAI SHOCK stage rather than a one-size-fits-all approach. Overall, there are 8 key concepts of CS; 1) the mortality associated with CS; 2) Shock attributed to AMI may be declining in both incidence and associated mortality; 3) providers should think about hemodynamic, metabolic, inflammation and cardiac function in totality to assess CS; 4) CS is a dynamic process; 5) no randomized trials evaluating use of the PAC in patients with CS; 6) most data supporting neosynephrine as first line agent in CS; 7) most registries suggest that almost half of CS patients do not have any mechanical support, and the vast majority of the remainder utilize the IABP; and 8) patients with AMI CS should receive emergent PCI of the culprit vessel., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Background: Patterns of dual antiplatelet therapy (DAPT) use beyond 1 year post-myocardial infarction (MI) have not been well studied., Methods: TIGRIS (NCT01866904) was a prospective, multi-center (369 centers in 24 countries), observational study of patients 1 to 3 years post-MI. We sought to identify the prevalence and determinants of DAPT use ≥1 year post-MI in patients enrolled in TIGRIS. We used multivariable logistic regression to identify determinants of DAPT use at 396 days post-MI (365 days plus a 31day overrun period to account for intended DAPT discontinuation at 1 year). Patients treated with an oral anticoagulant were excluded., Results: Of 7708 patients (median age 67 years, women 25%, ST-elevation MI 50%), 39% and 16% were on DAPT at 396 days and 5 years post-MI, respectively. DAPT use at 396 days post-MI was more prevalent in patients <65 years of age, treated with percutaneous coronary intervention (versus coronary artery bypass grafting or medical therapy), and with multivessel disease or a history of angina. Additional clinical determinants of ischemic and/or bleeding events following MI (diabetes, second prior MI, hypertension, peripheral artery disease, heart failure, smoking, and renal insufficiency) were not independently associated with DAPT use at 396 days. There were geographic variations in the use of DAPT at 396 days (p<0.001), with the lowest use in Europe and the highest in Asia and Australia., Conclusion: In a contemporary patient cohort, DAPT use beyond 1 year post MI was prevalent and associated with patient and index event characteristics. There were marked geographical variations in DAPT use beyond 1 year post MI., Competing Interests: Declaration of Competing Interest J.J.R. has received consulting honoraria from AstraZeneca. S.J.P. has received research grant support from AstraZeneca. A.T.Y. has received research grant support from AstraZeneca D.B. has received speaker/consulting honoraria and/or research grant support from Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, BMS, Eli Lilly, Merck, and Sanofi. R.O. has received research grant support from AstraZeneca. K.A.S. is an employee of AstraZeneca. C.B.G. has received consulting honoraria and/or research grant support from Armetheon, AstraZeneca, Bayer, Boehringer Ingelheim, BMS, Daiichi Sankyo, Eli Lilly, Gilead, GSK, Hoffmann La Roche, Janssen Pharmaceuticals, Medtronic, Pfizer, Salix Pharmaceuticals, Sanofi, Takeda, and The Medicines Company. M.G.C. has received speaker/consulting honoraria and/or research grant support from AstraZeneca, Medtronic, Abiomed, and Merit Medical. S.Y. has received speaker/consulting honoraria and/or research grant support from Takeda, Daiichi-Sankyo, AstraZeneca, Boehringer Ingelheim, Bristol-Myers. J.C.N. has received speaker/consulting honoraria and/or research grant support from Amgen, AstraZeneca, Bayer, BMS, Boehringer Ingelheim, GSK, Merck, Novartis, Pfizer, and Sanofi. G.B-W. is an employee of AstraZeneca. D.W. has received speaker/consulting honoraria and/or research grant support from AstraZeneca, Bayer, Berlin Chemie, Biotronik, and Novartis. T.S. has received speaker/consulting honoraria and/or research grant support from Astellas, Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Eli Lilly, GlaxoSmithKline, Merck, Novartis, Pfizer, and Sanofi. S.G.G. has received speaker/consulting honoraria and/or research grant support from Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, BMS, CSL Behring, Daiichi Sankyo, Eli Lilly, Fenix Group International, Ferring Pharmaceuticals, GlaxoSmithKline, Janssen/Johnson & Johnson, Luitpold Pharmaceuticals, Matrizyme, Merck, Novartis, Pfizer, Regeneron, Sanofi, Servier, and Tenax Pharmaceuticals., (Copyright © 2021. Published by Elsevier Ltd.)

Background: The Scoreflex NC scoring angioplasty catheter is designed with a short rapid-exchange tip distal to a non-compliant, high-pressure balloon and an integral wire outside of the balloon, such that the guidewire and the integral wire act as scoring elements during balloon inflation. The external scoring elements enable a focal stress pattern facilitating expansion of resistant lesions at lower pressures using a focused force angioplasty effect., Methods: Patients undergoing elective percutaneous coronary intervention (PCI) were enrolled in a prospective, single-arm study conducted at 12 centers in the United States. The primary endpoint was device procedural success, defined as the composite of successful device delivery to the target lesion with balloon inflation and deflation; absence of vessel perforation, flow-limiting dissection or reduction in TIMI flow from baseline; and achievement of final TIMI 3 flow., Results: Among 200 patients (234 lesions), lesion complexities included: bifurcation disease (37.6%), moderate/severe calcification (36.6%), and total occlusions (5.0%). Successful delivery to the target lesion, inflation and removal of the balloon catheter was achieved in 95.5% of patients (191/200). Procedural success was achieved in 93.5% (187/200) of patients, and final TIMI 3 flow was observed in 99.0% of cases (198/200). No unanticipated device-related events occurred. In-hospital major adverse events were reported in 4.5% of patients (9/200), related to periprocedural myocardial infarction (8/200, 4.0%) and target lesion revascularization (1/200, 0.5%)., Conclusions: Among patients undergoing elective PCI and with varied lesion complexity, these results support the safety and effectiveness of a dilation strategy using the Scoreflex NC scoring catheter., Competing Interests: Declaration of competing interest The following authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Dr. Kandzari reports institutional research/grant support from Abbott Vascular, Biotronik, Boston Scientific, Cardiovascular Systems, Inc., OrbusNeich, Medtronic and Ablative Solutions; and personal consulting honoraria from Cardiovascular Systems, Inc., Magenta Medical and Medtronic. Dr. Sanghvi reports institutional research/graft support from Boston Scientific, Cardiovascular system Inc., Recor Medical, Ablative solutions and personal consulting honoraria and royalty payments from Cordis Cardinal Health. Dr. Cohen reports personal consulting honoraria from Medtronic, Merit Medical, Terumo Medical, Astra Zeneca, Zoll, and Abiomed and ownership in Accumed Radial Systems. Dr. Almonacid reports institutional grants from Boston Scientific, Medtronic, Abbott Vascular, COOK, and Terumo. Drs. Hearne, Kumar, Sachdeva, Adams, Blossom, Dahle, Imperi and Riley declare no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Aim: The executive summary of the American College of Cardiology/American Heart Association/Society for Cardiovascular Angiography and Interventions coronary artery revascularization guideline provides the top 10 items readers should know about the guideline. In the full guideline, the recommendations replace the 2011 coronary artery bypass graft surgery guideline and the 2011 and 2015 percutaneous coronary intervention guidelines. This summary offers a patient-centric approach to guide clinicians in the treatment of patients with significant coronary artery disease undergoing coronary revascularization, as well as the supporting documentation to encourage their use., Methods: A comprehensive literature search was conducted from May 2019 to September 2019, encompassing studies, reviews, and other evidence conducted on human subjects that were published in English from PubMed, EMBASE, the Cochrane Collaboration, CINHL Complete, and other relevant databases. Additional relevant studies, published through May 2021, were also considered. Structure: Recommendations from the earlier percutaneous coronary intervention and coronary artery bypass graft surgery guidelines have been updated with new evidence to guide clinicians in caring for patients undergoing coronary revascularization. This summary includes recommendations, tables, and figures from the full guideline that relate to the top 10 take-home messages. The reader is referred to the full guideline for graphical flow charts, supportive text, and tables with additional details about the rationale for and implementation of each recommendation, and the evidence tables detailing the data considered in the development of this guideline.

Objective: To evaluate the impact of COVID-19 pandemic migitation measures on of ST-elevation myocardial infarction (STEMI) care., Background: We previously reported a 38% decline in cardiac catheterization activations during the early phase of the COVID-19 pandemic mitigation measures. This study extends our early observations using a larger sample of STEMI programs representative of different US regions with the inclusion of more contemporary data., Methods: Data from 18 hospitals or healthcare systems in the US from January 2019 to April 2020 were collecting including number activations for STEMI, the number of activations leading to angiography and primary percutaneous coronary intervention (PPCI), and average door to balloon (D2B) times. Two periods, January 2019-February 2020 and March-April 2020, were defined to represent periods before (BC) and after (AC) initiation of pandemic mitigation measures, respectively. A generalized estimating equations approach was used to estimate the change in response variables at AC from BC., Results: Compared to BC, the AC period was characterized by a marked reduction in the number of activations for STEMI (29%, 95% CI:18-38, p < .001), number of activations leading to angiography (34%, 95% CI: 12-50, p = .005) and number of activations leading to PPCI (20%, 95% CI: 11-27, p < .001). A decline in STEMI activations drove the reductions in angiography and PPCI volumes. Relative to BC, the D2B times in the AC period increased on average by 20%, 95%CI (-0.2 to 44, p = .05)., Conclusions: The COVID-19 Pandemic has adversely affected many aspects of STEMI care, including timely access to the cardiac catheterization laboratory for PPCI., (© 2020 Wiley Periodicals LLC.)

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Background: Limited data exist on current cardiogenic shock (CS) management strategies., Methods: A 48-item open- and closed-ended question survey on the diagnosis and management of CS., Results: A total of 211 respondents (3.2%) completed the survey, including 64% interventional cardiologists, 14% general cardiologists, 11% advanced heart failure cardiologists, 5% intensivists, 3% cardiothoracic surgeons; the remainder were internists, emergency medicine, and other physicians. Nearly half (45%) reported practicing at sites without advanced heart failure support/resources, with neither durable ventricular assist devices nor heart transplant available; 16% practice at sites without on-site cardiac surgery and 6% do not offer 24/7 percutaneous coronary intervention (PCI) coverage. The majority (70%) practice in closed intensive care units with multidisciplinary rounding (73%), cardiologists frequently involved in patient care (89%), and involving cardiology-intensivist co-management (41%). Over half (55%) reported use of CS protocols, 61% reported routine arterial line use, 25% reported routine use of pulmonary artery catheter use to guide management and 9% did not. The preferred vasopressor and/or inotrope was norepinephrine (68%). For coronary angiography and PCI, 53% use transradial access, 72% only revascularize the culprit vessel, and 44% institute mechanical circulatory support (MCS) prior to revascularization. Percutaneous MCS availability was as follows: intra-aortic balloon pump (92%), Impella (78%), peripheral veno-arterial extracorporeal membrane oxygenation (66%), and TandemHeart (28%). Most respondents (58%) do not use a scoring system for risk stratification and most (62%) reported that CS-specific cardiac rehabilitation programs were unavailable at their sites., Conclusion: Wide variation exists in the care delivered and/or resources available for patients with CS. Our survey suggests opportunities for standardization of care.

Transradial artery access (TRA) is associated with reduced bleeding risk, length of stay, costs, and increased patient satisfaction. Approximately one-third of TRA failures are due to lack of guiding catheter support. Catheter selection and engagement technique are crucial for obtaining good-quality angiograms and successfully completing percutaneous coronary intervention. The maneuvers required for catheter manipulation and coronary engagement differ between TRA and transfemoral arterial access. One of the advantages of TRA is the ability to use a universal catheter, saving time, radiation, and contrast. This review discusses practical learning points to improve operator understanding of catheter selection and coronary engagement technique., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Advanced age is directly related to worse outcomes following ST-elevation myocardial infarction (STEMI) and higher complication rates from antithrombotic therapies and primary percutaneous coronary intervention (PCI). Often excluded from clinical trials, seniors presenting with STEMI remain an understudied population despite contributing to 140,000 hospital admissions annually. The SAFE-STEMI for Seniors study is a prospective, multicenter, unblinded, randomized clinical trial designed to examine the efficacy and safety of instantaneous wave-free ratio-guided complete revascularization in multivessel disease, while also investigating other components of STEMI care for patients ≥60 years including the efficacy and safety of zotarolimus-eluting stents for primary PCI and transradial PCI with the Glidesheath Slender and TR band. The SAFE-STEMI trial represents North America's first and only prospective randomized investigational device exemption study to use a Coordinated Registry Network infrastructure with collaborative partnering across industry manufacturers, promoting both efficiency and reduced cost of evidence development for regulatory decisions related to both diagnostic and therapeutic technologies in a single study design. The study has been powered to evaluate 2 independent co-primary end points in a population of older patients with STEMI: (1) third-generation drug-eluting stents for primary PCI and (2) instantaneous wave-free ratio-guided complete revascularization versus infarct-related artery-only revascularization., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Background: Previous studies comparing outcomes between culprit vessel only percutaneous coronary intervention (CV-PCI) versus multivessel percutaneous coronary intervention (MV-PCI) in patients with cardiogenic shock in the setting of acute myocardial infarction have shown conflicting results. This meta-analysis investigates the optimal approach for management of these patients considering recently published data., Methods: Electronic databases including MEDLINE, ClinicalTrials.gov and the Cochrane Library were searched for all clinical studies published until May 1, 2018, which compared outcomes in patients presenting with acute myocardial infarction and cardiogenic shock. Studies comparing CV-PCI versus MV-PCI in patients with multivessel coronary artery disease were screened for inclusion in final analysis. The primary end point was in-hospital/30 day mortality. Secondary endpoints included long term (>6 months) mortality, renal failure requiring renal replacement therapy, stroke, bleeding, and recurrent myocardial infarction. Odds ratio (OR) with 95% of confidence interval (CI) were computed and p values <0.05 were considered significant., Results: Patient who underwent CV-PCI had significantly lower short-term mortality (in-hospital or 30-day mortality) (OR: 0.73, CI: 0.61-0.87, p = 0.0005), and lower odds of severe renal failure requiring renal replacement therapy (OR: 0.76, CI: 0.59-0.98, p = 0.03). There was no statistically significant difference in long-term mortality, stroke, bleeding, and recurrent myocardial infarction between two groups., Conclusion: This meta-analysis showed lower short-term mortality and decreased odds of renal failure requiring renal replacement therapy with CV-PCI compared to MV-PCI. However, subgroup analysis including studies exclusively assessing STEMI patients revealed no statistically significant difference in outcomes. Further randomized trials are needed to confirm these findings and evaluate long term results., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Background: Older adults ≥75 years of age carry an increased risk of mortality after ST-segment elevation myocardial infarction (STEMI) complicated by cardiogenic shock., Objectives: The purpose of this study was to examine the use of percutaneous coronary intervention (PCI) in older adults with STEMI and shock and its influence on in-hospital mortality., Methods: We used a large publicly available all-payer inpatient health care database sponsored by the Agency for Healthcare Research and Quality between 1999 and 2013. The primary outcome was in-hospital mortality. The influence of PCI on in-hospital mortality was assessed by quintiles of propensity score (PS)., Results: Of the 317,728 encounters with STEMI and shock in the United States, 111,901 (35%) were adults age ≥75 years. Of these, 53% were women and 83% were Caucasians. The median number of chronic conditions was 8 (interquartile range: 6 to 10). The diagnosis of STEMI and cardiogenic shock in older patients decreased significantly over time (proportion of older adults with STEMI and shock: 1999: 42% vs. 2013: 29%). Concomitantly, the rate of PCI utilization in older adults increased (1999: 27% vs. 2013: 56%, p < 0.001), with declining in-hospital mortality rates (1999: 64% vs. 2013: 46%; p < 0.001). Utilizing PS matching methods, PCI was associated with a lower risk of in-hospital mortality across quintiles of propensity score (Mantel-Haenszel odds ratio: 0.48; 95% confidence interval [CI]: 0.45 to 0.51). This reduction in hospital mortality risk was seen across the 4 different U.S. census bureau regions (adjusted odds ratio: Northeast: 0.41; 95% CI: 0.36 to 0.47; Midwest: 0.49; 95% CI: 0.42 to 0.57; South: 0.51; 95% CI: 0.46 to 0.56; West: 0.46; 95% CI: 0.41 to 0.53)., Conclusions: This large and contemporary analysis shows that utilization of PCI in older adults with STEMI and cardiogenic shock is increasing and paralleled by a substantial reduction in mortality. Although clinical judgment is critical, older adults should not be excluded from early revascularization based on age in the absence of absolute contraindications., (Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Despite improvements in acute care and survival after non-ST-elevation acute coronary syndrome (NSTE-ACS) hospitalization, early readmissions remain common, and have significant clinical and financial impact., Objectives: Determine the predictors and etiologies of 30-day readmissions in NSTE-ACS., Method: The study cohort was derived from the National Readmission Database 2014 identifying patients with a primary diagnosis of NSTE-ACS using ICD9 code., Results: We identified a total of 300,269 patients admitted with NSTE-ACS; 13.4% were readmitted within 30-day. The most common cause of readmission was heart failure (HF) (15.6%), followed by a recurrent myocardial infarction (MI) (10%). Predictors of increased readmissions were age ≥ 75 years (OR: 1.34, 95% CI: 1.30-1.39), female gender (OR 1.12, 95% CI 1.09-1.16), a Charlson Comorbidity Index (CCI) >3 (OR 2.11, 95% CI: 2.04-2.18), ESRD (OR 2.01, 95% CI 1.89-2.14), CKD (OR: 1.58, 95% CI: 1.51-1.64), length of stay ≥5 days (OR: 1.51, 95% CI 1.46-1.56) and adverse events during the index admission such as AKI (OR:1.31, 95% CI: 1.25-1.36), major bleeding (OR:1.20, 95% CI: 1.12-1.24); whereas admission to a teaching hospital (OR 0.92, 95% CI 0.89-0.95) and PCI (OR 0.70, 95% CI 0.67-0.72) were associated with less likelihood of 30-day readmission., Conclusion: Readmission rate at 30-days is high among NSTE-ACS patients and the most common readmission etiologies are HF and recurrent MI. A CCI more than 3 and ESRD were the most significant predictors for readmission; patients undergoing PCI had less odds of readmission., (© 2018 Wiley Periodicals, Inc.)

Background: Although many studies show an inverse association between operator procedural volume and short-term adverse outcomes after percutaneous coronary intervention (PCI), the association between procedural volume and longer-term outcomes is unknown., Methods: Using the National Cardiovascular Data Registry CathPCI registry data linked with Medicare claims data, we examined the association between operator PCI volume and long-term outcomes among patients ≥65 years of age. Operators were stratified by average annual PCI volume (counting PCIs performed in patients of all ages): low- (<50 PCIs), intermediate- (50-100), and high- (>100) volume operators. One-year unadjusted rates of death and major adverse coronary events (MACEs; defined as death, readmission for myocardial infarction, or unplanned coronary revascularization) were calculated with Kaplan-Meier methods. The proportional hazards assumption was not met, and risk-adjusted associations between operator volume and outcomes were calculated separately from the time of PCI to hospital discharge and from hospital discharge to 1-year follow-up., Results: Between July 1, 2009, and December 31, 2014, 723 644 PCI procedures were performed by 8936 operators: 2553 high-, 2878 intermediate-, and 3505 low-volume operators. Compared with high- and intermediate-volume operators, low-volume operators more often performed emergency PCI, and their patients had fewer cardiovascular comorbidities. Over 1-year follow-up, 15.9% of patients treated by low-volume operators had a MACE compared with 16.9% of patients treated by high-volume operators ( P=0.004). After multivariable adjustment, intermediate- and high-volume operators had a significantly lower rate of in-hospital death than low-volume operators (odds ratio, 0.91; 95% CI, 0.86-0.96 for intermediate versus low; odds ratio, 0.79; 95% CI, 0.75-0.83 for high versus low). There were no significant differences in rates of MACEs, death, myocardial infarction, or unplanned revascularization between operator cohorts from hospital discharge to 1-year follow-up (adjusted hazard ratio for MACEs, 0.99; 95% CI, 0.96-1.01 for intermediate versus low; hazard ratio, 1.01; 95% CI, 0.99-1.04 for high versus low)., Conclusions: Unadjusted 1-year outcomes after PCI were worse for older adults treated by operators with higher annual volume; however, patients treated by these operators had more cardiovascular comorbidities. After risk adjustment, higher operator volume was associated with lower in-hospital mortality and no difference in postdischarge MACEs.

Background Percutaneous coronary intervention with drug-eluting stents (DES) has been increasingly used for revascularization of saphenous vein graft stenosis without strong clinical evidence favoring their use. Randomized controlled trials comparing DES versus bare-metal stents (BMS) in saphenous vein graft-percutaneous coronary intervention have been inconclusive. Methods and Results We performed a comprehensive literature search through May 15, 2018, for all eligible studies comparing DES versus BMS in patients with saphenous vein graft stenosis in PubMed, EMBASE, SCOPUS, Google Scholar, and ClinicalTrials.gov. Clinical outcomes included all-cause mortality, cardiovascular mortality, major adverse cardiovascular events, myocardial infarction, stent thrombosis, and target vessel revascularization. Six randomized controlled trials were eligible and included 1582 patients, of whom 797 received DES and 785 received BMS. The follow-up period ranged from 18 months to 60 months. There was no statistically significant difference between DES and BMS for all-cause mortality (risk ratio [RR],1.11; 95% CI, 0.0.77-1.62; P=0.57), cardiovascular mortality (RR, 1.00; 95% CI, 0.64-1.57; P=0.99), major adverse cardiovascular events (RR, 0.83; 95% CI, 0.63-1.10; P=20), target vessel revascularization (RR, 0.73; 95% CI, 0.48-1.11; P=0.14), myocardial infarction (RR, 0.74; 95% CI, 0.48-1.16; P=0.19), or stent thrombosis (RR, 1.06; 95% CI, 0.42-2.65; P=0.90). Conclusions In patients undergoing percutaneous coronary intervention for saphenous vein graft lesions, our results showed that there was no significant difference between DES and BMS for mortality, major adverse cardiovascular events, target vessel revascularization, myocardial infarction, or stent thrombosis.

Importance: Same-day discharge (SDD) after elective percutaneous coronary intervention (PCI) is associated with lower costs and preferred by patients. However, to our knowledge, contemporary patterns of SDD after elective PCI with respect to the incidence, hospital variation, trends, costs, and safety outcomes in the United States are unknown., Objective: To examine (1) the incidence and trends in SDD; (2) hospital variation in SDD; (3) the association between SDD and readmissions for bleeding, acute kidney injury (AKI), acute myocardial infarction (AMI), or mortality at 30, 90, and 365 days after PCI; and (4) hospital costs of SDD and its drivers., Design, Setting, and Participants: This observational cross-sectional cohort study included 672 470 patients enrolled in the nationally representative Premier Healthcare Database who underwent elective PCI from 493 hospitals between January 2006 and December 2015 with 1-year follow-up., Exposures: Same-day discharge, defined by identical dates of admission, PCI procedure, and discharge., Main Outcomes and Measures: Death, bleeding requiring a blood transfusion, AKI and AMI at 30, 90, or 365 days after PCI, and costs from hospitals' perspective, inflated to 2016., Results: Among 672 470 elective PCIs, 221 997 patients (33.0%) were women, 30 711 (4.6%) were Hispanic, 51 961 (7.7%) were African American, and 491 823 (73.1%) were white. The adjusted rate of SDD was 3.5% (95% CI, 3.0%-4.0%), which increased from 0.4% in 2006 to 6.3% in 2015. We observed substantial hospital variation for SDD from 0% to 83% (median incidence rate ratio, 3.82; 95% CI, 3.48-4.23), implying an average (median) 382% likelihood of SDD at one vs another hospital. Among SDD (vs non-SDD) patients, there was no higher risk of death, bleeding, AKI, or AMI at 30, 90, or 365 days. Same-day discharge was associated with a large cost savings of $5128 per procedure (95% CI, $5006-$5248), driven by reduced supply and room and boarding costs. A shift from existing SDD practices to match top-decile SDD hospitals could annually save $129 million in this sample and $577 million if adopted throughout the United States. However, residual confounding may be present, limiting the precision of the cost estimates., Conclusions and Relevance: Over 2006 to 2015, SDD after elective PCI was infrequent, with substantial hospital variation. Given the safety and large savings of more than $5000 per PCI associated with SDD, greater and more consistent use of SDD could markedly increase the overall value of PCI care.

Transradial artery access for percutaneous coronary intervention is associated with lower bleeding and vascular complications than transfemoral artery access, especially in patients with acute coronary syndromes. A growing body of evidence supports adoption of transradial artery access to improve acute coronary syndrome-related outcomes, to improve healthcare quality, and to reduce cost. The purpose of this scientific statement is to propose and support a "radial-first" strategy in the United States for patients with acute coronary syndromes. This document also provides an update to previously published statements on transradial artery access technique and best practices, particularly as they relate to the management of patients with acute coronary syndromes.

Innovations in interventional cardiology historically predate those in neuro-intervention. As such, studying trends in interventional cardiology can be useful in exploring avenues to optimise neuro-interventional techniques. One such cardiology innovation has been the steady conversion of arterial puncture sites from transfemoral access (TFA) to transradial access (TRA), a paradigm shift supported by safety benefits for patients. While neuro-intervention has unique anatomical challenges, the access itself is identical. As such, examining the extensive cardiology literature on the radial approach has the potential to offer valuable lessons for the neuro-interventionalist audience who may be unfamiliar with this body of work. Therefore, we present here a report, particularly for neuro-interventionalists, regarding the best practices for TRA by reviewing the relevant cardiology literature. We focused our review on the data most relevant to our audience, namely that surrounding the access itself. By reviewing the cardiology literature on metrics such as safety profiles, cost and patient satisfaction differences between TFA and TRA, as well as examining the technical nuances of the procedure and post-procedural care, we hope to give physicians treating complex cerebrovascular disease a broader data-driven understanding of TRA., Competing Interests: Competing interests: None declared., (© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.)

Introduction: Transfemoral access (TFA) is widely used for coronary angiography and percutaneous coronary intervention (PCI). The influence of operator age, gender, experience, and procedural volume on performance of femoral arterial access has not been studied., Methods: A survey instrument was developed and distributed via e-mail from professional societies to interventional cardiologists worldwide from March to December 2016., Results: A total of 988 physicians from 88 countries responded to the survey. TFA is the preferred approach for patients with cardiogenic shock, left main or bifurcation PCI, and procedures with mechanical circulatory support. Older (<50years: 56.4%; ≥50years: 66.8%, p<0.0039) and high PCI volume operators (<100 PCI: 57.3%; 100-299 PCI: 58.7%; ≥300 PCI: 64.3%, p<0.134) preferred palpation only without imaging (fluoroscopy or ultrasound (US)) for TFA. Most respondents preferred not to use micropuncture needle to puncture the femoral artery. Older (≥50years: 64.4%; <50years: 71.5%, p<0.04) and high PCI volume operators (≥300 PCI: 64.1%; 100-299 PCI: 72.6%; <100 PCI: 67.9%, p<0.072) tended not to perform femoral angiography (FA). Of those performing FA, the majority opted to do it at the end of the procedure., Conclusion: Despite best practice guideline recommendations, older and high PCI volume interventional cardiologists prefer not to use imaging for femoral access or perform femoral angiography during TF procedures. These data highlight opportunities to further reduce TFA complications., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Objectives: The aim of this study was to examine the current practice and use of transfemoral approach (TFA) for coronary angiography and intervention., Background: Wide variability exists in TFA techniques for coronary procedures., Methods: The authors developed a survey instrument that was distributed via e-mail lists from professional societies to interventional cardiologists from 88 countries between March and December 2016., Results: Of 987 operators, 18% were femoralists, 38% radialists, 42% both, and 2% neither. Access using femoral pulse palpation alone was preferred by 60% of operators, fluoroscopy guidance by 11%, and a combination of palpation, fluoroscopy, or ultrasound by 27%. Only 11% used micropuncture in >90% of their cases. Performing femoral angiography immediately after access was preferred by 23% and at the end of the procedure by 47%, and not done at all by 31% of operators. Hemostasis by manual compression was preferred by 50%, collagen plug vascular closure device by 31%, and suture-based vascular closure device by 11% of operators. Judkins left and right catheters were preferred for diagnostic angiography of the left (99%) and right (94%) coronary arteries. Extra backup curves (XB or EBU) were most commonly preferred for percutaneous coronary intervention of the left anterior descending (80%) and left circumflex (80%), whereas the Judkins right catheter was preferred for percutaneous coronary intervention of the right coronary artery (86%)., Conclusions: There is significant variability in preferences for femoral access technique. Even though recommended best practices advocate for fluoroscopic and ultrasound guidance, most operators use palpation alone. Femoral angiography is also not consistently used despite guideline recommendations. The lack of adoption of imaging guidance for vascular access deserves further investigation., (Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objective: To analyze trends in management and outcomes of patients infected with the human immunodeficiency virus (HIV) undergoing percutaneous coronary intervention (PCI) for an acute myocardial infarction (AMI) in the United States., Background: Infection with HIV is an independent risk factor for accelerated atherosclerosis associated with higher rates of AMI. Current trends and outcomes of HIV-infected individuals presenting with AMI in the United States remain unknown., Methods: Using the Healthcare Cost and Utilization Project National Inpatient Sample database we identified HIV-infected individuals who underwent PCI for an AMI from 2002 to 2013. Multivariable logistic regression and propensity-score matching were performed to analyze outcomes., Results: We identified a total of 59 194 patients of which 7841 underwent PCI during index hospitalization (13.3%). Most patients were men (71%), ≥50 years of age (82%), and white (74%). ST-elevation myocardial infarction was present in 21% of cases. Charlson comorbidity index (CCI) was 5.67 ± 0.4. Predictors of post-procedural complications included female sex, black race, higher CCI, and placement of a bare metal stent, whereas predictors of mortality included occurrence of a complication, ST-elevation myocardial infarction, age ≥70 years, and higher CCI. Conversely, placement of a drug-eluting stent was associated with a reduced risk of complications and mortality. After propensity-score matching, HIV-infected individuals were less likely to undergo PCI and receive a drug-eluting stent, while having longer length of stay, higher hospitalization costs, and higher in-hospital mortality when compared to non-infected individuals., Conclusion: Significant disparities continue to affect HIV-infected individuals undergoing PCI for AMI in the United States., (© 2017, Wiley Periodicals, Inc.)

Introduction: Impella is a catheter-based micro-axial flow pump placed across the aortic valve, and it is currently the only percutaneous left ventricular assist device approved for high-risk percutaneous coronary intervention and cardiogenic shock. Areas Covered: Even though several studies have repeatedly demonstrated the excellent hemodynamic profile of Impella in high-risk settings, it remains underutilized. Here we aim to provide an up-to-date summary of the available literature on Impellas use in High risk settings as well as the practical aspects of its usage. Expert Commentary: Percutaneous coronary interventions in high rsk settings have always been challenging for a physician. Impella 2.5 and CP, have been proven safe, cost effective and feasible in High Risk Percutaneous coronary Interventions with an excellent hemodynamic profile.

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: 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., (Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Transcatheter aortic valve replacement (TAVR) with percutaneous coronary intervention (PCI) has emerged as a less-invasive therapeutic option for high surgical risk patients with aortic stenosis and coronary artery disease. The aim of this study was to determine the outcomes of TAVR when performed with PCI during the same hospitalization. We identified patients using the International Classification of Diseases, Ninth Revision, Clinical Modification procedure codes from the Nationwide Inpatient Sample between the years 2011 and 2013. A total of 22,344 TAVRs were performed between 2011 and 2013. Of these, 21,736 (97.3%) were performed without PCI (TAVR group) while 608 (2.7%) along with PCI (TAVR + PCI group). Among the TAVR + PCI group, 69.7% of the patients had single-vessel, 22.2% had 2-vessel, and 1.6% had 3-vessel PCI. Drug-eluting stents were more commonly used than bare-metal stents (72% vs 28%). TAVR + PCI group witnessed significantly higher rates of mortality (10.7% vs 4.6%) and complications: vascular injury requiring surgery (8.2% vs 4.2%), cardiac (25.4% vs 18.6%), respiratory (24.6% vs 16.1%), and infectious (10.7% vs 3.3%), p <0.001% for all, compared with the TAVR group. The mean length of hospital stay and cost of hospitalization were also significantly higher in the TAVR + PCI group. The propensity score-matched analysis yielded similar results. In conclusion, performing PCI along with TAVR during the same hospital admission is associated with higher mortality, complications, and cost compared with TAVR alone. Patients would perhaps be better served by staged PCI before TAVR., (Copyright © 2016. Published by Elsevier Inc.)

Importance: The 2015 cardiopulmonary resuscitation and emergency cardiovascular care guidelines recommend performing coronary angiography in resuscitated patients after cardiac arrest with or without ST-segment elevation (STE)., Objective: To assess the temporal trends, predictors, and outcomes of performing coronary angiography and percutaneous coronary intervention (PCI) in patients resuscitated after out-of-hospital cardiac arrest (OHCA) with initial rhythms of ventricular tachycardia or pulseless ventricular fibrillation (VT/VF)., Design, Setting, and Participants: An observational analysis of the use of coronary angiography and PCI in 407 974 patients hospitalized after VT/VF OHCA from January 1, 2000, through December 31, 2012, from the Nationwide Inpatient Sample database. Multivariable analysis was used to assess factors associated with coronary angiography and PCI use. Data analysis was performed from December 12, 2015, to January 5, 2016., Main Outcomes and Measures: Temporal trends of coronary angiography, PCI, and survival to discharge in patients with VT/VF OHCA., Results: Among the 407 974 patients hospitalized after VT/VF OHCA, 143 688 (35.2%) were selected to undergo coronary angiography. The mean (SD) age of the total population was 65.7 (14.9) years, 37.9% were female, and 74.1% were white, 13.4% black, 6.8% Hispanic, and 5.7% other race. Use of coronary angiography increased from 27.2% in 2000 to 43.9% in 2012 (odds ratio, 2.47; 95% CI, 2.25-2.71; P for trend < .001), and PCI increased from 9.5% in 2000 to 24.1% in 2012 (odds ratio, 4.80; 95% CI, 4.21-5.66; P for trend < .001). From 2000 to 2012, coronary angiography and PCI after VT/VF OHCA increased in patients with STE (53.7% to 87.2%, P for trend < .001, and 29.7% to 77.3%, P for trend < .001, respectively) and those without STE (19.3% to 33.9%, P for trend < .001, and 3.5% to 11.8%, P for trend < .001, respectively). There was an associated increasing trend in survival to discharge in the overall population of patients with VT/VF OHCA (46.9% to 60.1%, P for trend < .001) in those with STE (59.2% to 74.3%, P for trend < .001) or without STE (43.3% to 56.8%, P for trend < .001)., Conclusions and Relevance: Coronary angiography, PCI, and survival to discharge have increased in VT/VF OHCA survivors from event to hospitalization. However, a significant proportion of patients with VT/VF OHCA, especially those without STE, do not undergo coronary angiography and revascularization. Prospective studies are needed to determine whether this limitation has a survival effect.

Patients with severe coronary artery disease with a clinical indication for revascularization but who are at high procedural risk because of patient comorbidities, complexity of coronary anatomy, and/or poor hemodynamics represent an understudied and potentially underserved patient population. Through advances in percutaneous interventional techniques and technologies and improvements in patient selection, current percutaneous coronary intervention may allow appropriate patients to benefit safely from revascularization procedures that might not have been offered in the past. The burgeoning interest in these procedures in some respects reflects an evolutionary step within the field of percutaneous coronary intervention. However, because of the clinical complexity of many of these patients and procedures, it is critical to develop dedicated specialists within interventional cardiology who are trained with the cognitive and technical skills to select these patients appropriately and to perform these procedures safely. Preprocedural issues such as multidisciplinary risk and treatment assessments are highly relevant to the successful treatment of these patients, and knowledge gaps and future directions to improve outcomes in this emerging area are discussed. Ultimately, an evolution of contemporary interventional cardiology is necessary to treat the increasingly higher-risk patients with whom we are confronted., (© 2016 American Heart Association, Inc.)

The objective of our study was to assess patients with end-stage liver disease undergoing percutaneous coronary intervention (PCI) and determine the rates and trend of complications and in-hospital outcomes. Data were obtained from the Nationwide Inpatient Sample 2005 to 2012. We identified all PCIs performed in patients with diagnosis of cirrhosis during the study period by the International Classification of Diseases, Ninth Revision, Clinical Modification codes. Preventable procedural complications were identified by Patient Safety Indicators. Propensity scoring method was used to establish matched cohorts to control for imbalances and account for differences that may have influenced treatment outcomes. A total of 1,051,242 PCIs were performed during the study period, of these, 122,342 were done on subjects with a formal diagnosis of cirrhosis. Bare-metal stents (BMS) were more likely to be used in patients who presented with ST-elevation myocardial infarction (19.73 vs 13.58, p <0.001), in cardiogenic shock (5.58, vs 2.81, p <0.001), or required intraaortic balloon pump (4.73 vs 2.38, p <0.001). The overall rate of complications was 7.1%, whereas the overall mortality rate over these years was 3.63%. On a propensity-matched analysis the mortality rate was 2 times higher for BMS (5.18 vs 2.35, p <0.001) compared with drug-eluting stents. PCI remains a safe and plausible option for patients with cirrhosis albeit riskier than for the general population. The use of BMS is associated with increased mortality and bleeding complications compared with drug-eluting stents which likely is representative of preferential use of BMS in patients with more advanced end-stage liver disease who are also likely to experience higher postprocedural complications., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Percutaneous coronary intervention (PCI) is an integral treatment modality for acute coronary syndromes (ACS) as well as chronic stable coronary artery disease (CAD) not responsive to optimal medical therapy. This coupled with studies on the feasibility and safety of performing PCI in centers without on-site surgical backup led to widespread growth of PCI centers. However, this has been accompanied by a recent steep decline in the volume of PCIs at both the operator and hospital level, which raises concerns regarding minimal procedural volumes required to maintain necessary skills and favorable clinical outcomes. The 2011 ACC/AHA/SCAI competency statement required PCI be performed by operators with a minimal procedural volume of >75 PCIs annually at high-volume centers with >400 PCIs per year, a number which was relaxed in the 2013 ACC/AHA/SCAI update to >50 PCIs/operator/year in hospitals with >200 PCIs annually to coincide with reduction in national PCI volume. Recent data suggests that many hospitals do not meet these thresholds. We review data on the importance of volume as a vital quality metric at both an operator and hospital level in determining procedural outcomes following PCI.

Our aim was to evaluate the influence of chronic total occlusions (CTOs) on long-term clinical outcomes of patients with coronary heart disease and diabetes mellitus. We evaluated patients with coronary heart disease and diabetes mellitus enrolled in the Bypass Angioplasty Revascularization Investigation 2 Diabetes, who underwent either prompt revascularization (PR) with intensive medical therapy (IMT) or IMT alone according to the presence or absence of CTO. Of 2,368 patients enrolled in the trial, 972 patients (41%) had CTO of coronary arteries. Of those, 482 (41%) and 490 (41%) were in the PR with IMT versus IMT only groups, respectively. In the PR group, patients with CTO were more likely to be selected for the coronary artery bypass grafting stratum (coronary artery bypass grafting 62% vs percutaneous coronary intervention 31%, p <0.001). Compared to the non-CTO group, patients with CTO had more abnormal Q wave, abnormal ST depression, and abnormal T waves. The myocardial jeopardy score was higher in the CTO versus non-CTO group (52 [36 to 69] vs 37 [21 to 53], p <0.001). After adjustment, 5-year mortality rate was significantly higher in the CTO group in the entire cohort (hazard ratio [HR] 1.35, p = 0.013) and in patients with CTO managed with IMT (HR 1.46, p = 0.031). However, the adjusted risk of death was not increased in patients managed with PR (HR 1.26, p = 0.180). In conclusion, CTO of coronary arteries is associated with increased mortality in patients treated medically. However, the presence of a CTO may not increase mortality in patients treated with revascularization. Larger randomized trials are needed to evaluate the effects of revascularization on long-term survival in patients with CTO., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Background: REG1 is a novel anticoagulation system consisting of pegnivacogin, an RNA aptamer inhibitor of coagulation factor IXa, and anivamersen, a complementary sequence reversal oligonucleotide. We tested the hypothesis that near complete inhibition of factor IXa with pegnivacogin during percutaneous coronary intervention, followed by partial reversal with anivamersen, would reduce ischaemic events compared with bivalirudin, without increasing bleeding., Methods: We did a randomised, open-label, active-controlled, multicentre, superiority trial to compare REG1 with bivalirudin at 225 hospitals in North America and Europe. We planned to randomly allocate 13,200 patients undergoing percutaneous coronary intervention in a 1:1 ratio to either REG1 (pegnivacogin 1 mg/kg bolus [>99% factor IXa inhibition] followed by 80% reversal with anivamersen after percutaneous coronary intervention) or bivalirudin. Exclusion criteria included ST segment elevation myocardial infarction within 48 h. The primary efficacy endpoint was the composite of all-cause death, myocardial infarction, stroke, and unplanned target lesion revascularisation by day 3 after randomisation. The principal safety endpoint was major bleeding. Analysis was by intention to treat. This trial is registered at ClinicalTrials.gov, identifier NCT01848106. The trial was terminated early after enrolment of 3232 patients due to severe allergic reactions., Findings: 1616 patients were allocated REG1 and 1616 were assigned bivalirudin, of whom 1605 and 1601 patients, respectively, received the assigned treatment. Severe allergic reactions were reported in ten (1%) of 1605 patients receiving REG1 versus one (<1%) of 1601 patients treated with bivalirudin. The composite primary endpoint did not differ between groups, with 108 (7%) of 1616 patients assigned REG1 and 103 (6%) of 1616 allocated bivalirudin reporting a primary endpoint event (odds ratio [OR] 1·05, 95% CI 0·80-1·39; p=0·72). Major bleeding was similar between treatment groups (seven [<1%] of 1605 receiving REG1 vs two [<1%] of 1601 treated with bivalirudin; OR 3·49, 95% CI 0·73-16·82; p=0·10), but major or minor bleeding was increased with REG1 (104 [6%] vs 65 [4%]; 1·64, 1·19-2·25; p=0·002)., Interpretation: The reversible factor IXa inhibitor REG1, as currently formulated, is associated with severe allergic reactions. Although statistical power was limited because of early termination, there was no evidence that REG1 reduced ischaemic events or bleeding compared with bivalirudin., Funding: Regado Biosciences Inc., (Copyright © 2016 Elsevier Ltd. All rights reserved.)

Objectives: To compare the utilization and outcomes in patients who had percutaneous coronary interventions (PCIs) performed with intra-aortic balloon pump (IABP) versus percutaneous ventricular assist devices (PVADs) such as Impella and TandemHeart and identify a sub-group of patient population who may derive the most benefit from the use of PVADs over IABP., Background: Despite the lack of clear benefit, the use of PVADs has increased substantially in the last decade when compared to IABP., Methods: We performed a cross sectional study including using the Nationwide Inpatient Sample. Procedures performed with hemodynamic support were identified through appropriate ICD-9-CM codes., Results: We identified 18,094 PCIs performed with hemodynamic support. IABP was the most commonly utilized hemodynamic support device (93%, n = 16, 803) whereas 6% (n = 1069) were performed with PVADs and 1% (n = 222) utilized both IABP and PVAD. Patients in the PVAD group were older in age and had greater burden of co-morbidities whereas IABP group had higher percentage of patients with cardiac arrest. On multivariable analysis, the use of PVAD was a significant predictor of reduced mortality (OR 0.55, 0.36-0.83, P = 0.004). This was particularly evident in sub-group of patients without acute MI or cardiogenic shock. The propensity score matched analysis also showed a significantly lower mortality (9.9% vs 15.1%; OR 0.62, 0.55-0.71, P < 0.001) rate associated with PVADs when compared to IABP., Conclusion: This largest and the most contemporary study on the use of hemodynamic support demonstrates significantly reduced mortality with PVADs when compared to IABP in patients undergoing PCI. The results are largely driven by the improved outcomes in non-AMI and non-cardiogenic shock patients., (© 2015, Wiley Periodicals, Inc.)

Background: The Trial of Routine Aspiration Thrombectomy with PCI versus PCI alone in patients with STEMI (TOTAL trial) refuted the salutary effect of routine aspiration thrombectomy (AT) in PPCI for patients with ST-elevation myocardial infarction (STEMI)., Objectives: We performed an updated meta-analysis to assess clinical outcomes with AT prior to PPCI compared with conventional PPCI alone including the additional trial data., Methods and Results: Clinical trials (n = 20) that randomized patients (n = 21,281) with STEMI between Routine AT (n = 10,619) and PPCI (n = 10,662) were pooled. There was no difference in all-cause mortality between the 2 groups (RR: 0.89, 95%CI: 0.78-1.01, P = 0.08). Stratifying by follow up at 1-month (RR: 0.87, 95%CI: 0.69-1.10, P = 0.25), up to 6 months (RR: 0.91, 95%CI: 0.74-1.13, P = 0.39 and beyond 6 months (RR: 0.88, 95%CI: 0.74-1.05, P = 0.16) yielded similar results. There was a statistically significant increase risk of stoke rate in the AT arm (RR: 1.51, 95%CI: 1.01-2.25, P = 0.04). The 2 groups were similar with regards to target vessel revascularization (0.94, 95%CI: 0.83-1.06, P = 0.28) recurrent MI (RR: 0.96, 95%CI: 0.80-1.16, P = 0.68, MACE events (RR: 0.91 95%CI: 0.81-1.02, P = 0.11), early (0.59, 95%CI: 0.23-1.50, P = 0.27) and late (RR: 0.91, 95%CI: 0.69-1.18, P = 0.47) stent thrombosis and net clinical benefit (RR 0.99, 95%CI: 0.91-1.07, P = 0.76)., Conclusion: Routine AT prior to PPCI in STEMI is associated with higher risk of stroke. There is no statistical difference in clinical outcome parameters of mortality, major adverse cardiac events, target vessel revascularization, stent thrombosis, and net clinical benefit between AT and PCI alone., (© 2015, Wiley Periodicals, Inc.)

Background: High-risk percutaneous coronary intervention (PCI) supported by percutaneous left ventricular assist devices offers a treatment option for patients with severe symptoms, complex and extensive coronary artery disease, and multiple comorbidities. The extrapolation from clinical trial to real-world practice has inherent uncertainties. We compared the characteristics, procedures, and outcomes of high-risk PCI supported by a microaxial pump (Impella 2.5) in a multicenter registry versus the randomized PROTECT II trial (NCT00562016)., Methods: The USpella registry is an observational multicenter voluntary registry of Impella technology. A total of 637 patients treated between June 2007 and September 2013 were included. Of them, 339 patients would have met enrollment criteria for the PROTECT II trial. These were compared with 216 patients treated in the Impella arm of PROTECT II., Results: Compared to the clinical trial, registry patients were older (70 ± 11.5 vs 67.5 ± 11.0 years); more likely to have chronic kidney disease (30% vs 22.7%), prior myocardial infarction (69.3% vs 56.5%), or prior bypass surgery (39.4% vs. 30.2%); and had similar prevalence of diabetes, peripheral vascular disease, and prior stroke. Registry patients had more extensive coronary artery disease (2.2 vs 1.8 diseased vessels) and had a similar Society of Thoracic Surgeons predicted risk of mortality. At hospital discharge, registry patients experienced a similar reduction in New York Heart Association class III to IV symptoms compared to trial patients. Registry patients had a trend toward lower in-hospital mortality (2.7% vs 4.6, P = .27)., Conclusions: USpella provides a real-world and contemporary estimation of the type of procedures and outcomes of high-risk patients undergoing PCI supported by Impella 2.5. Despite the higher risk of registry patients, clinical outcomes appeared to be favorable and consistent compared with the randomized trial., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Purpose of Review: Optimal anticoagulation is needed to prevent ischemic complications during percutaneous coronary interventions (PCIs). The efficacy and safety of new anticoagulants to support PCI in different clinical scenarios have been evaluated in large clinical trials. This review summarizes the major issues and current practices for anticoagulation during PCI., Recent Findings: It is known that thrombotic events during PCI correlate with poor prognosis. However, the prognostic impact of bleeding is similar or even worse compared with ischemic complications. Therefore, the use of more predictable anticoagulants and safe practices in the catheterization laboratory to balance ischemia and bleeding is an important goal. Mindful of this notion, new anticoagulants with a safer profile, such as bivalirudin, have become popular to avoid bleeding. However, this paradigm shift has resulted in increased rates of acute stent thrombosis after primary PCI., Summary: Individual factors associated with increased bleeding risk should be considered in the choice of anticoagulants during PCI. It is now known that the higher bleeding risk observed with heparin-based regimens can be attributed to excessive doses or concomitant use of glycoprotein IIbIIIa inhibitors. In addition to the right anticoagulant choice, operators can avoid bleeding by implementing transradial access and ultrasound-guided and fluoroscopic-guided vascular access.

The use of percutaneous aortic balloon balvotomy (PABV) in high surgical risk patients has resurged because of development of less invasive endovascular therapies. We compared outcomes of concomitant PABV and percutaneous coronary intervention (PCI) with PABV alone during same hospitalization using nation's largest hospitalization database. We identified patients and determined time trends using the International Classification of Diseases, Ninth Revision, Clinical Modification, procedure code for valvulotomy from Nationwide Inpatient Sample database 1998 to 2010. Only patients >60 years with aortic stenosis were included. Primary outcome included in-hospital mortality, and secondary outcomes included procedural complications, length of stay (LOS), and cost of hospitalization. Total 2,127 PABV procedures were identified, with 247 in PABV + PCI group and 1,880 in the PABV group. Utilization rate of concomitant PABV + PCI during same hospitalization increased by 225% from 5.1% in 1998 to 1999 to 16.6% in 2009 to 2010 (p <0.001). Overall in-hospital mortality rate and complication rates in PABV + PCI group were similar to that of PABV group (10.3% vs 10.5% and 23.4% vs 24.7%, respectively). PABV + PCI group had similar LOS but higher hospitalization cost (median [interquartile range] $30,089 [$21,925 to $48,267] versus $18,421 [$11,482 to $32,215], p <0.001) in comparison with the PABV group. Unstable condition, occurrence of any complication, and weekend admission were the main predictors of increased LOS and cost of hospital admission. Concomitant PCI and PABV during the same hospitalization are not associated with change in in-hospital mortality, complications rate, or LOS compared with PABV alone; however, it increases the cost of hospitalization., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Background: The relationship between operator or institutional volume and outcomes among patients undergoing percutaneous coronary interventions (PCI) is unclear., Methods and Results: Cross-sectional study based on the Healthcare Cost and Utilization Project's Nationwide Inpatient Sample between 2005 to 2009. Subjects were identified by International Classification of Diseases, 9(th) Revision, Clinical Modification procedure code, 36.06 and 36.07. Annual operator and institutional volumes were calculated using unique identification numbers and then divided into quartiles. Three-level hierarchical multivariate mixed models were created. The primary outcome was in-hospital mortality; secondary outcome was a composite of in-hospital mortality and peri-procedural complications. A total of 457,498 PCIs were identified representing a total of 2,243,209 PCIs performed in the United States during the study period. In-hospital, all-cause mortality was 1.08%, and the overall complication rate was 7.10%. The primary and secondary outcomes of procedures performed by operators in 4(th) [annual procedural volume; primary and secondary outcomes] [>100; 0.59% and 5.51%], 3(rd) [45-100; 0.87% and 6.40%], and 2(nd) quartile [16-44; 1.15% and 7.75%] were significantly less (P<0.001) when compared with those by operators in the 1(st) quartile [≤15; 1.68% and 10.91%]. Spline analysis also showed significant operator and institutional volume outcome relationship. Similarly operators in the higher quartiles witnessed a significant reduction in length of hospital stay and cost of hospitalization (P<0.001)., Conclusions: Overall in-hospital mortality after PCI was low. An increase in operator and institutional volume of PCI was found to be associated with a decrease in adverse outcomes, length of hospital stay, and cost of hospitalization., (© 2014 American Heart Association, Inc.)

Background: We determined the contemporary trends of percutaneous aortic balloon valvotomy and its outcomes using the nation's largest hospitalization database. There has been a resurgence in the use of percutaneous aortic balloon valvotomy in patients at high surgical risk because of the development of less-invasive endovascular therapies., Methods: This is a cross-sectional study with time trends using the Nationwide Inpatient Sample database between the years 1998 and 2010. We identified patients using the International Classification of Diseases, 9th Revision, Clinical Modification procedure code for valvotomy. Only patients aged more than 60 years with aortic stenosis were included. Primary outcome included in-hospital mortality, and secondary outcomes included procedural complications and length of hospital stay., Results: A total of 2127 percutaneous aortic balloon valvotomies (weighted n = 10,640) were analyzed. The use rate of percutaneous aortic balloon valvotomy increased by 158% from 12 percutaneous aortic balloon valvotomies per million elderly patients in 1998-1999 to 31 percutaneous aortic balloon valvotomies per million elderly patients in 2009-2010 in the United States (P < .001). The hospital mortality decreased by 23% from 11.5% in 1998-1999 to 8.8% in 2009-2010 (P < .001). Significant predictors of in-hospital mortality were the presence of increasing comorbidities (P = .03), unstable patient (P < .001), any complication (P < .001), and weekend admission (P = .008), whereas increasing operator volume was associated with significantly reduced mortality (P = .03). Patients who were admitted to hospitals with the highest procedure volume and the highest volume operators had a 51% reduced likelihood (P = .05) of in-hospital mortality when compared with those in hospitals with the lowest procedure volume and lowest volume operators., Conclusion: This study comprehensively evaluates trends for percutaneous aortic balloon valvotomy in the United States and demonstrates the significance of operator and hospital volume on outcomes., (Copyright © 2014 Elsevier Inc. All rights reserved.)

Aims: We sought to determine the feasibility of conducting percutaneous coronary intervention (PCI) in high-risk acute coronary syndrome (ACS) patients utilising the REG1 system consisting of pegnivacogin, an aptameric factor IXa inhibitor, and its controlling agent anivamersen., Methods and Results: In RADAR, ACS patients were randomised to pegnivacogin 1 mg/kg with 25%, 50%, 75%, or 100% anivamersen reversal or unfractionated heparin. Of the 640 patients randomised, 388 (61%) underwent PCI. Major modified ACUITY 30-day bleeding rates were 18% (25% reversal), 12% (50% reversal), 9% (75% reversal), and 7% (100% reversal), compared with 11% with heparin. The corresponding total bleeding rates were 68%, 39%, 35%, 34%, and 38% (heparin). Ischaemic events were less frequent in those receiving pegnivacogin versus heparin (4.4% vs. 7.3%, p=0.3). Thirty-day urgent TVR (1.1% vs. 0.9%, p=1.0), myocardial infarction (4.0% vs. 6.4%, p=0.3), and angiographic complication (11.2% and 10.8%, p=0.9) rates were similar with pegnivacogin and heparin. There were no incidences of clot formation on guidewires or catheters., Conclusions: High-level factor IXa inhibition in ACS patients undergoing PCI, with at least 50% reversal, has a favourable bleeding profile and appears effective at suppressing ischaemic events and thrombotic complications. Larger phase trials in PCI are warranted., Clinical Trials Registration: ClinicalTrials.gov NCT00932100.

Objective: To study rotational atherectomy (RA) outcomes in patients undergoing high-risk PCI randomized to receive hemodynamic support using either IABP or Impella 2.5 in the PROTECT II trial., Background: RA of heavily calcified lesions is often necessary for complex PCI but can be associated with slow-flow, hypotension, and higher risk of periprocedural MI., Methods: We compared baseline, angiographic, procedural characteristics, and outcomes of patients treated with and without RA. We examined also RA technique and outcomes., Results: RA was used in 52 of 448 patients (32 with Impella vs 20 with IABP, P = 0.08). RA patients were older (72 vs. 67 yo, P = 0.0009), more likely to have prior CABG (48 vs. 32%, P = 0.017), higher STS (8.1 vs. 5.7, P = 0.012) and higher SYNTAX scores (37 vs. 29, P < 0.0001). At 90 days, RA use was associated with higher incidence of MI but no mortality difference. RA was used more aggressively with Impella resulting in higher rate of periprocedural MI (P < 0.01), with no difference in mortality between groups (P = 0.78). Repeat revascularization occurred less frequently with Impella (P < 0.001). There were no differences in 90-day major adverse events between IABP and Impella in patients undergoing RA (P = 0.29). In patients not treated with RA, fewer MAEs were observed with Impella compared with IABP (P = 0.03)., Conclusions: Patients who were treated with RA had more comorbidities, and more complex and extensive coronary artery disease. In patients with Impella, more aggressive RA use resulted in fewer revascularization events but higher incidence of periprocedural MI., (Copyright © 2013 Wiley Periodicals, Inc.)

Background: RADAR compared REG1 (25%, 50%, 75%, 100% reversal) with unfractionated heparin (UFH) in 640 acute coronary syndrome (ACS) patients (479 REG1 patients, 161 UFH patients) undergoing an invasive management strategy. We sought to determine whether the REG1 anticoagulation system allows for safer early arterial sheath removal following cardiac catheterization., Methods: REG1 patients had arterial sheath removal immediately post catheterization. We measured arterial sheath management outcomes and vascular access complications in patients who had sheath removal without vascular closure device implantation; 461 patients were included (349 REG1 patients, 112 UFH patients)., Results: The median (25th, 75th) time from end of catheterization to arterial sheath removal was shorter in REG1 arms regardless of reversal strategy (26 minutes [18, 46]) compared with UFH (210 minutes [102, 342]). There was no increase in median time from sheath removal to hemostasis (10 minutes [10, 20] and 10 minutes [10, 20]; P=.60); vascular access-site bleeding complications were numerically fewer with REG1 than UFH (6% vs 11%; odds ratio [OR], 0.57; 95% CI, 0.27-1.18; P=.14). There were no differences in time to ambulation or hospital length of stay between the groups., Conclusions: REG1 allows for very early arterial sheath removal following cardiac catheterization without increasing the time to hemostasis or vascular access-site bleeding complications. Further studies are needed to determine whether anticoagulation with REG1 will translate into shorter hospital lengths of stay and reduced costs in ACS patients.

Background: Radial access for percutaneous coronary intervention (r-PCI) is associated with reduced vascular complications; however, previous reports have shown that <2% of percutaneous coronary intervention (PCI) procedures in the United States are performed via the radial approach. Our aims were to evaluate temporal trends in r-PCI and compare procedural outcomes between r-PCI and transfemoral PCI., Methods and Results: We conducted a retrospective cohort study from the CathPCI registry (n=2 820 874 procedures from 1381 sites) between January 2007 and September 2012. Multivariable logistic regression models were used to evaluate the adjusted association between r-PCI and bleeding, vascular complications, and procedural success, using transfemoral PCI as the reference. Outcomes in high-risk subgroups such as age ≥75 years, women, and patients with acute coronary syndrome were also examined. The proportion of r-PCI procedures increased from 1.2% in quarter 1 2007 to 16.1% in quarter 3 2012 and accounted for 6.3% of total procedures from 2007 to 2012 (n=178 643). After multivariable adjustment, r-PCI use in the studied cohort of patients was associated with lower risk of bleeding (adjusted odds ratio, 0.51; 95% confidence interval, 0.49-0.54) and lower risk of vascular complications (adjusted odds ratio, 0.39; 95% confidence interval, 0.31-0.50) in comparison with transfemoral PCI. The reduction in bleeding and vascular complications was consistent across important subgroups of age, sex, and clinical presentation., Conclusions: There has been increasing adoption of r-PCI in the United States. Transradial PCI now accounts for 1 of 6 PCIs performed in contemporary clinical practice. In comparison with traditional femoral access, transradial PCI is associated with lower vascular and bleeding complication rates.

Objectives: To evaluate feasibility and technical outcomes in patients with aortic stenosis (AS) who have undergone high-risk procedures with continuous flow left ventricular (LV) assist, with the Impella 2.5 system (Abiomed, Danvers, MA)., Background: In preparation for transcatheter aortic valve implantation, an increasing number of high-risk patients with severe AS and left ventricular dysfunction are currently considered for percutaneous coronary interventions (PCI) and balloon aortic valvuloplasty (BAV). Hemodynamic support may be required in some patients., Methods: We reviewed procedural and clinical findings and 30-day outcomes in patients with symptomatic AS who underwent high-risk percutaneous procedures supported by the Impella 2.5 system. All patients carried a high-risk of operative mortality. Impella was used during PCI, BAV, and for hemodynamic support during emergencies., Results: Over a 14-month period, 21 patients with AS underwent insertion of Impella prior to high-risk PCI (n = 3), BAV with subsequent PCI (n = 8), BAV alone (n = 7), or during cardiac arrest immediately following BAV (n = 3). The mean Society of Thoracic Surgeons (STS) predicted mortality risk was 14% (range 7.3-24.7%). Impella was inserted successfully in all patients attempted. Retrograde advancement of two catheters across the aortic valve (for concomitant BAV in 15 patients) was technically feasible. Retrograde continuous flow LV assist produced a reduction in LV end-diastolic pressure and an increase in arterial pressure. Periprocedural complications occurred in 19% (n = 4) patients, with no periprocedural deaths. Mortality at 30 days was 14.2%., Conclusion: Our data suggests that continuous flow LV assist with Impella 2.5 can be used in high-risk patients with severe AS who require periprocedural hemodynamic support., (Copyright © 2012 Wiley Periodicals, Inc.)