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COVID-19, percutaneous coronary intervention, ST elevation myocardial infarction. [Extracted from the article]

Abstract: Objectives: We sought to examine the effects of escalating doses of omega-3 polyunsaturated fatty acid (PUFA) supplements on platelet function using light transmission aggregometry (LTA) and electrophoretic quasi-elastic light scattering technology (EQELS). Background: PUFA may inhibit platelet function through fatty acid substitution in the platelet membrane by changing the surface charge density and causing decreased production of thromboxane A2. EQELS can measure platelet surface charge density and determine whether the platelet is in resting or activated state. Methods: A total of 30volunteers were divided in 3 groups of 10 as follows: Group A, no antiplatelet agent; Group B, daily aspirin only, and Group C, daily aspirin and clopidogrel. All patients received escalating doses of omega-3PUFA from 1 to 8g daily over 24weeks. Platelet function was measured by template bleeding time, LTA, and EQELS at baseline and at 6, 12, 18 and 24weeks. Results: Mean bleeding time increased in a dose-dependent manner with escalating omega-3 PUFA doses. LTA confirmed expected antiplatelet effects of aspirin and clopidogrel, but did not detect any additional antiplatelet effects of omega-3 PUFA. EQELS showed a significant increase in the negative resting platelet charge compared to baseline and an attenuated response to arachidonic acid mediated platelet activation. No bleeding events were observed. Conclusions: In this pilot study we were able to successfully measure platelet surface charge variation as a measure of omega-3 PUFA effect on platelets. Our results suggest that omega-3 PUFA increase the total platelet surface charge and, therefore, attenuate platelet activation, even among patients taking aspirin or aspirin plus clopidogrel. Further studies are needed to determine the clinical significance of these measured effects and EQELS results. [Copyright &y& Elsevier]

Periprocedural bleeding complications after percutaneous coronary intervention (PCI) are associated with increased short- and long-term morbidity and mortality. Although clinical trials have primarily assessed pharmacological strategies for reducing bleeding risk, there is a mounting body of evidence suggesting that adoption of a transradial rather than a transfemoral approach to PCI may permit greater reductions in bleeding risk than have been achieved with pharmacological strategies alone. However, despite a long history of use, a lack of widespread uptake by physicians coupled with the technological limitations of available devices has in the past confined transradial PCI to the status of a niche procedure, and many operators lack experience in this technique. In this review, we examine the history of the transradial approach to PCI and discuss some of the circumstances that have hitherto limited its appeal. We then review the current state of the peer-reviewed literature supporting its use and summarize the unresolved issues affecting broader application of this technique, including lack of operator familiarity and an insufficient evidence base for guiding practice. Finally, we describe potential directions for future investigation in the transradial realm. [Copyright &y& Elsevier]

Abstract: Purpose: To correlate pulmonary artery catheterization (PAC) use and 30-day outcomes and to characterize the use of pulmonary artery catheters among patients with acute coronary syndromes (ACS). Subjects and methods: We retrospectively studied 26437 ACS patients from two large multicenter, international randomized clinical trials. Multivariable and causal inference analyses were applied to adjust for differences in baseline risk. Results: PAC was performed in 735 patients (2.8%), with a median time to insertion of 24 hours. Patients undergoing PAC were older (median, 67 vs. 64 years), more often diabetic (25.7% vs.16.2%), and more likely to present with ST-segment elevation (81.6% vs. 70.2%) or Killip class III or IV (7.9% vs. 1.4%). US patients were 3.8 times more likely than non-US patients to undergo PAC. Patients managed with PAC also underwent more procedures, including percutaneous intervention (40.7% vs. 18.1%), coronary artery bypass grafting (12.5% vs. 7.7%), and endotracheal intubation (29.3% vs. 2.2%). Mortality at 30 days was substantially higher among patients with PAC for both unadjusted (odds ratio [OR] 8.7; 95% confidence interval [CI] 7.3–10.2) and adjusted analyses (OR 6.4; 95% CI 5.4–7.6) in all groups except in patients with cardiogenic shock (OR 0.99; 95% CI 0.80–1.23). Conclusions: PAC was associated with increased mortality, both before and after adjustment for baseline patient differences and subsequent events that may have led to PAC use, except in patients with cardiogenic shock. The definitive role of PAC in managing patients with ACS is still to be determined. [Copyright &y& Elsevier]

In preclinical experiments, the combination of transcutaneous, low-frequency ultrasound and thrombolytic therapy has shown improved patency rates over thrombolytics alone. A total of 25 patients with myocardial infarction were treated with a thrombolytic agent and adjunctive transcutaneous ultrasound. No unanticipated major adverse events were observed. [Copyright &y& Elsevier]

Examines procedural, in-hospital and long-term outcomes of patients undergoing small coronary artery stenting with Palmaz-Schatz stents hand-crimped on a balloon catheter. Suggestion that stents designed for vessels greater than three millimeters can be deployed in small vessels with a low in-hospital event rate; High lesion revascularization in small vessels.

Comments on the use of drug-eluting stents in the treatment of myocardial infarction. Impact of drug-eluting stents on the success of interventional cardiology; History of the use of drug-eluting stents in clinical practice in the U.S.; Potential efficacy of drug-eluting stents in the treatment of unstable patients; Assessment of the risk for stent thrombosis; Reference to a clinical trial on the use of drug-eluting stents in patients with ST-segment elevation myocardial infarction (STEMI); Critique of the study's design and outcome; View that drug-eluting stents are superior to bare-metal stents in the treatment of myocardial infarction.

Objectives: This study sought to determine the incidence of new-onset atrial fibrillation (AF) associated with different methods of isolated aortic valve replacement (AVR)—transfemoral (TF), transapical (TA), and transaortic (TAo) catheter-based valve replacement and conventional surgical approaches. Background: The relative incidences of AF associated with the various access routes for AVR have not been well characterized. Methods: In this single-center, retrospective cohort study, we evaluated a total of 231 consecutive patients who underwent AVR for degenerative aortic stenosis (AS) between March 2010 and September 2012. Patients with a history of paroxysmal, persistent, or chronic AF, with bicuspid aortic valves, and patients who died within 48 h after AVR were excluded. A total of 123 patients (53% of total group) qualified for inclusion. Data on documented episodes of new-onset AF, along with all clinical, echocardiographic, procedural, and 30-day follow-up data, were collated. Results: AF occurred in 52 patients (42.3%). AF incidence varied according to the procedural method. AF occurred in 60% of patients who underwent surgical AVR (SAVR), in 53% after TA-TAVR, in 33% after TAo-TAVR cases, and 14% after TF-TAVR. The episodes occurred at a median time interval of 53 (25th to 75th percentile, 41 to 87) h after completion of the procedure. Procedures without pericardiotomy had an 82% risk reduction of AF compared with those with pericardiotomy (adjusted odds ratio: 0.18; 95% confidence interval: 0.05 to 0.59). Conclusions: AF was a common complication of AVR with a cumulative incidence of >40% in elderly patients with degenerative AS who underwent either SAVR or TAVR. AF was most common with SAVR and least common with TF-TAVR. Procedures without pericardiotomy were associated with a lower incidence of AF. [Copyright &y& Elsevier]

Transcatheter aortic valve implantation (TAVI) has emerged as a therapeutic alternative for patients with symptomatic aortic stenosis at high or prohibitive surgical risk. However, patients undergoing TAVI are also at high risk for both bleeding and stroke complications, and specific mechanical aspects of the procedure itself can increase the risk of these complications. The mechanisms of periprocedural bleeding complications seem to relate mainly to vascular/access site complications (related to the use of large catheters in a very old and frail elderly population), whereas the pathophysiology of cerebrovascular events remains largely unknown. Further, although mechanical complications, especially the interaction between the valve prosthesis and the native aortic valve, may play a major role in events that occur during TAVI, post-procedural events might also be related to a prothrombotic environment or state generated by the implanted valve, the occurrence of atrial arrhythmias, and associated comorbidities. Antithrombotic therapy in the setting of TAVI has been empirically determined, and unfractionated heparin during the procedure followed by dual antiplatelet therapy with aspirin (indefinitely) and clopidogrel (1 to 6 months) is the most commonly recommended treatment. However, bleeding and cerebrovascular events are common; these may be modifiable with optimization of periprocedural and post-procedural pharmacology. Further, as the field of antiplatelet and anticoagulant therapy evolves, potential drug combinations will multiply, introducing variability in treatment. Randomized trials are the best path forward to determine the balance between the efficacy and risks of antithrombotic treatment in this high risk-population. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Abstract: Acute coronary syndrome is the number one killer in the industrialized world and, as such, continues to be one of the most well-studied disease states in all of medicine. Advancements in antiplatelet therapies for use in patients undergoing percutaneous coronary intervention have improved outcomes dramatically. However, a proportion of patients on long-term antiplatelet therapy continue to have cardiovascular events. Resistance to antiplatelet drugs may explain some of these events and this topic has become one of major interest and rapid evolution. This review describes the pathogenesis of acute coronary syndromes, outlines the evidence behind the use of the available antiplatelet agents, and examines the current data surrounding antiplatelet resistance. [Copyright &y& Elsevier]

The effect of the contrast agent iohexol on reference vessel size in patients with proximal left anterior descending disease is unknown. Quantitative coronary angiography and intravascular ultrasound were performed in 15 patients with atherosclerotic disease of the proximal left anterior descending. Mean proximal reference vessel diameter was 2.95 ± 0.59 mm with quantitative coronary angiography and 4.65 ± 0.66 mm with intravascular ultrasound (P < .05). Intracoronary injection of iohexol resulted in a significant decrease in intravascular ultrasound-measured proximal reference vessel diameter from 4.65 ± 0.66 mm to 4.47 ± 0.68 mm (P = .002). Vasoconstrictive response to iohexol in the proximal reference vessel ranged from ?0.04 mm to 0.5 mm with a mean of 0.18 ± 0.16 mm. This study shows that iohexol can cause significant vasoconstriction of the proximal reference vessel in patients with severe disease involving the proximal left anterior descending. [ABSTRACT FROM AUTHOR]

Keywords: AHA Scientific Statements; percutaneous coronary intervention; angioplasty; coronary artery bypass graft surgery; myocardial infarction; cardiac surgery; stent(s); angiogram; angiography; percutaneous transluminal coronary angioplasty; coronary atherosclerosis; saphenous vein graft; internal mammary artery graft; internal thoracic artery graft; arterial graft; post-bypass; non-ST-segment-elevated myocardial infarction; vein graft lesions; myocardial revascularization; multivessel PCI; left ventricular dysfunction EN AHA Scientific Statements percutaneous coronary intervention angioplasty coronary artery bypass graft surgery myocardial infarction cardiac surgery stent(s) angiogram angiography percutaneous transluminal coronary angioplasty coronary atherosclerosis saphenous vein graft internal mammary artery graft internal thoracic artery graft arterial graft post-bypass non-ST-segment-elevated myocardial infarction vein graft lesions myocardial revascularization multivessel PCI left ventricular dysfunction e18 e114 97 01/21/22 20220118 NES 220118 SP * sp Writing committee members are required to recuse themselves from voting on sections to which their specific relationships with industry may apply; see Appendix 1 for detailed information. Patients who are most appropriate for complete revascularization at the time of primary PCI include those with uncomplicated PCI of the infarct artery and with low-complexity non-infarct artery disease who have normal left ventricular filling pressures and normal renal function. Recommendation-Specific Supportive Text After controlling for greater baseline comorbidities among patients undergoing revascularization, several observational studies have demonstrated that Black,[28],[52] Hispanic,[24],[50] and Asian [55],[56] patients have outcomes similar to those of White patients. [Extracted from the article]

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. [ABSTRACT FROM AUTHOR]

Aim: The guideline for coronary artery revascularization replaces the 2011 coronary artery bypass graft surgery and the 2011 and 2015 percutaneous coronary intervention guidelines, providing 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: Coronary artery disease remains a leading cause of morbidity and mortality globally. Coronary revascularization is an important therapeutic option when managing patients with coronary artery disease. The 2021 coronary artery revascularization guideline provides recommendations based on contemporary evidence for the treatment of these patients. The recommendations present an evidence-based approach to managing patients with coronary artery disease who are being considered for coronary revascularization, with the intent to improve quality of care and align with patients' interests. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Over the past few decades, advances in pharmacological, catheter-based, and surgical reperfusion have improved outcomes for patients with acute myocardial infarctions. However, patients with large infarcts or those who do not receive timely revascularization remain at risk for mechanical complications of acute myocardial infarction. The most commonly encountered mechanical complications are acute mitral regurgitation secondary to papillary muscle rupture, ventricular septal defect, pseudoaneurysm, and free wall rupture; each complication is associated with a significant risk of morbidity, mortality, and hospital resource utilization. The care for patients with mechanical complications is complex and requires a multidisciplinary collaboration for prompt recognition, diagnosis, hemodynamic stabilization, and decision support to assist patients and families in the selection of definitive therapies or palliation. However, because of the relatively small number of high-quality studies that exist to guide clinical practice, there is significant variability in care that mainly depends on local expertise and available resources. [ABSTRACT FROM AUTHOR]

Evidence is lacking on long-term outcomes in unselected patients surviving the first year following myocardial infarction (MI). The TIGRIS (long-Term rIsk, clinical manaGement and healthcare Resource utilization of stable coronary artery dISease in post-myocardial infarction patients) prospective registry enrolled 9176 eligible patients aged ≥50 years, 1–3 years post-MI, from 25 countries. All had ≥1 risk factor: age ≥ 65 years, diabetes mellitus, second prior MI, multivessel coronary artery disease, chronic kidney disease (CKD). Primary outcome was a composite of MI, unstable angina with urgent revascularization, stroke, or all-cause death at 2-year follow-up. Bleeding requiring hospitalization was also recorded. 9027 patients (98.4%) provided follow-up data: the primary outcome occurred in 621 (7.0%), all-cause mortality in 295 (3.3%), and bleeding in 109 (1.2%) patients. Events accrued linearly over time. In multivariable analyses, qualifying risk factors were associated with increased risk of primary outcome (incidence rate ratio [RR] per 100 patient-years [95% confidence interval]): CKD 2.06 (1.66, 2.55), second prior MI 1.71 (1.38, 2.10), diabetes mellitus 1.63 (1.39, 1.92), age ≥ 65 years 1.53 (1.28, 1.83), and multivessel disease 1.24 (1.05, 1.48). Risk of bleeding events was greater in older patients (vs <65 years) 65–74 years 2.68 (1.53, 4.70), ≥75 years 4.62 (2.57, 8.28), and those with CKD 1.99 (1.18, 3.35). In stable patients recruited 1–3 years post-MI, recurrent cardiovascular and bleeding events accrued linearly over 2 years. Factors independently predictive of ischemic and bleeding events were identified, providing a context for deciding on treatment options. • TIGRIS enrolled stable patients 1–3 years post-MI, all with ≥1 risk factor. • Among 9027 patients, the primary outcome occurred in 7.0%. • All qualifying risk factors were associated with increased risk of primary outcome. • Older age and chronic kidney disease were associated with increased bleeding risk. • These findings provide a context for treatment decisions. [ABSTRACT FROM AUTHOR]

Longevity is increasing, and more adults are living to the stage of life when age-related biological factors determine a higher likelihood of cardiovascular disease in a distinctive context of concurrent geriatric conditions. Older adults with cardiovascular disease are frequently admitted to cardiac intensive care units (CICUs), where care is commensurate with high age-related cardiovascular disease risks but where the associated geriatric conditions (including multimorbidity, polypharmacy, cognitive decline and delirium, and frailty) may be inadvertently exacerbated and destabilized. The CICU environment of procedures, new medications, sensory overload, sleep deprivation, prolonged bed rest, malnourishment, and sleep is usually inherently disruptive to older patients regardless of the excellence of cardiovascular disease care. Given these fundamental and broad challenges of patient aging, CICU management priorities and associated decision-making are particularly complex and in need of enhancements. In this American Heart Association statement, we examine age-related risks and describe some of the distinctive dynamics pertinent to older adults and emerging opportunities to enhance CICU care. Relevant assessment tools are discussed, as well as the need for additional clinical research to best advance CICU care for the already dominating and still expanding population of older adults. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Risk-averse behavior has been reported among physicians and facilities treating cardiogenic shock in states with public reporting. Our objective was to evaluate if public reporting leads to a lower use of mechanical circulatory support in cardiogenic shock. We conducted a retrospective study with the use of the National Inpatient Sample from 2005 to 2011. Hospitalizations of patients ≥18 years old with a diagnosis of cardiogenic shock were included. A regional comparison was performed to identify differences between reporting and nonreporting states. The main outcome of interest was the use of mechanical circulatory support. A total of 13043 hospitalizations for cardiogenic shock were identified of which 9664 occurred in reporting and 3379 in nonreporting states (age 69.9 ± 0.4 years, 56.8% men). Use of mechanical circulatory support was 32.8% in this high-risk population. Odds of receiving mechanical circulatory support were lower (OR 0.50; 95% CI 0.43-0.57; p < 0.01) and in-hospital mortality higher (OR 1.19; 95% CI 1.06-1.34; p < 0.01) in reporting states. Use of mechanical circulatory support was also lower in the subgroup of patients with acute myocardial infarction and cardiogenic shock in reporting states (OR 0.61; 95% CI 0.51-0.72; p < 0.01). In conclusion, patients with cardiogenic shock in reporting states are less likely to receive mechanical circulatory support than patients in nonreporting states. [ABSTRACT FROM AUTHOR]

Background: Complete heart block is a known complication after transcatheter aortic valve replacement (TAVR), often requiring pacemaker implantation within 24 hours of the procedure. However, clinical markers for delayed progression to complete heart block after TAVR remain unclear. Objectives: We examined electrocardiographic data that may correlate with delayed progression to complete heart block and need for pacemaker. Methods: This is a single‐center retrospective study of 608 patients who underwent TAVR between April 2008 and June 2017. We excluded 164 (27.0%) patients due to having a pacemaker before the procedure or expiring within 24 hours of the procedure (8, 1.3%). We excluded an additional 50 (8.2%) patients who received a pacemaker within 24 hours of the procedure. Electrocardiograms (EKGs) obtained after the procedure were compared to the preprocedural EKG to detect new changes. Results: Left bundle branch block, intraventricular conduction delay, left anterior fascicular block, and right bundle branch block were the most commonly seen conduction abnormalities after TAVR (25.1%, 10.9%, 7.5%, and 3.6%, respectively). Both left bundle branch block (odds ratio [OR] = 2.77 [95% confidence interval (CI): 1.24–6.22]) and right bundle branch block (OR = 13.2 [95% CI: 4.18–41.70]) carried an increased risk of pacemaker implantation after TAVR. Additionally, ΔPR greater than 40 ms from baseline also carried an increased risk of pacemaker implantation (OR = 3.53 [95% CI: 1.49–8.37]). Conclusion: Left bundle branch block, right bundle branch block, and ΔPR greater than 40 ms were all associated with delayed progression to complete heart block and need for pacemaker implantation after TAVR. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Introduction: Over the recent years, there has been increased interest in the use of transradial (TR) access for percutaneous coronary intervention (PCI), including rotational atherectomy (RA). However, a large proportion of operators seem to be reluctant to use TR access for complex PCI including rotational atherectomy for heavily calcified coronary lesions.Methods: We searched MEDLINE, ClinicalTrials.gov and the Cochrane Library for studies comparing radial versus femoral access in patients undergoing RA. Studies were included if they reported at least one of the following outcomes in each group separately: major adverse cardiac events (MACE), major bleeding, stent thrombosis, myocardial infarction (MI), hospital length of stay, radiation exposure, procedure time, procedure success and all-cause mortality. Odds ratio (OR) or mean difference (MD) with 95% confidence interval (CI) were calculated and a p-value of <0.05 was considered as a level of significance.Results: This meta-analysis included 5 retrospective studies with 3315 patients undergoing RA via radial access and 5838 patients via femoral access. Radial access was associated with lower major access site bleeding (OR: 0.45, 95% CI: 0.31-0.67, p < 0.001), and radiation exposure (MD: -16.1, 95%CI: -25.4--6.7 Gy cm2, p = 0.0007). There were no significant differences observed in all-cause in-hospital mortality (OR: 0.92, 95% CI: 0.69-1.23, p = 0.58); MACE (OR: 0.80, CI: 0.63, 1.02, p = 0.08), stent thrombosis (OR: 0.28, 95%CI: 0.06-1.33 p = 0.11); and MI (OR: 0.43, 95%CI: 0.15-1.24, p = 0.12). There were no significant differences in hospital stay, procedure time or procedure success between the two groups (p > 0.05).Conclusion: This meta-analysis of 9153 patients from observational studies demonstrates similar all-cause mortality, MACE, procedural success and procedural time during RA performed using TR access and TF access. However, TR access was associated with decreased access site bleeding and radiation exposure. Given the observational nature of these findings, a randomized controlled trial is warranted for further evidence. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Objective: This study sought to examine the trends and predictors of mechanical circulatory support (MCS) use in patients hospitalized after out-of-hospital cardiac arrest (OHCA).Background: There is a paucity of data regarding MCS use in patients hospitalized after OHCA.Methods: We conducted an observational analysis of MCS use in 960,428 patients hospitalized after OHCA between January 2008 and December 2014 in the Nationwide Inpatient Sample database. On multivariable analysis, we also assessed factors associated with MCS use and survival to discharge.Results: Among the 960,428 patients, 51,863 (5.4%) had MCS utilized. Intra-aortic balloon pump (IABP) was the most commonly used MCS after OHCA with frequency of 47,061 (4.9%), followed by extracorporeal membrane oxygenation (ECMO) 3650 (0.4%), and percutaneous ventricular assist devices (PVAD) 3265 (0.3%). From 2008 to 2014, there was an increase in the utilization of MCS from 5% in 2008 to 5.7% in 2014 (P trend < 0.001). There was a non-significant decline in the use of IABP from 4.9% to 4.7% (P trend = 0.95), whereas PVAD use increased from 0.04% to 0.7% (P trend < 0.001), and ECMO use increased from 0.1% to 0.7% (P trend < 0.001) during the study period. Younger, male patients with myocardial infarction, higher co-morbid conditions, VT/VF as initial rhythm, and presentation to a large urban hospital were more likely to receive percutaneous MCS implantation. Survival to discharge was significantly higher in patients who were selected to receive MCS (56.9% vs. 43.1%, OR: 1.16, 95% CI: (1.11-1.21), p < 0.001).Conclusions: There is a steady increase in the use of MCS in OHCA, especially PVAD and ECMO, despite lack of randomized clinical trial data supporting an improvement in outcomes. More definitive randomized studies are needed to assess accurately the optimal role of MCS in this patient population. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Cardiogenic shock is a high-acuity, potentially complex, and hemodynamically diverse state of end-organ hypoperfusion that is frequently associated with multisystem organ failure. Despite improving survival in recent years, patient morbidity and mortality remain high, and there are few evidence-based therapeutic interventions known to clearly improve patient outcomes. This scientific statement on cardiogenic shock summarizes the epidemiology, pathophysiology, causes, and outcomes of cardiogenic shock; reviews contemporary best medical, surgical, mechanical circulatory support, and palliative care practices; advocates for the development of regionalized systems of care; and outlines future research priorities. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Importance Optimal strategies for glucose control in very old adults with diabetes and stable ischemic heart disease (SIHD) are unclear. Objective To compare the effects of insulin provision (IP) therapy versus insulin sensitizing (IS) therapy for glycemic control in older (≥ 75 years) and younger (< 75 years) adults with type II diabetes (DM) and SIHD. Design, setting, and participants Adults enrolled in the Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) were studied. The BARI 2D study population (all with type II DM and SIHD) was randomized twice: (1) between revascularization plus intensive medical therapy versus intensive medical therapy alone, and (2) between IP versus IS therapies. The primary endpoint was all-cause-mortality over five-year follow-up. In this substudy outcomes related to IP vs. IS are assessed in relation to age. Adults aged ≥ 75 years who received IP versus IS are compared to those < 75 years who received IP versus IS. Multivariate Cox regression analysis was used to evaluate the effects of IP vs. IS on outcomes in the two age groups. Results 2368 subjects with SIHD and DM were enrolled in BARI 2D; 182 (8%) were ≥ 75 years. Compared to younger subjects, the older cohort had lower BMI, higher diuretic use, worse kidney function, and increased history of heart failure. Within the older cohort, the IP and IS subgroups were similar in respect to baseline cardiovascular risk factors, medications, and coronary artery disease severity. During follow-up, the older subjects receiving IP therapy had higher cardiovascular mortality compared to those receiving IS therapy (16% vs. 11%, p = 0.040). Using Cox proportional hazards analysis, the older IP subjects were at increased risk for all-cause-mortality (hazard ratio 1.89, CI 1.1–3.2, p = 0.020). No mortality difference between IP and IS was observed in those < 75 years of age. Conclusion and relevance Among adults with diabetes and SIHD aged ≥ 75 years, IP therapy may be associated with increased mortality compared to IS therapy. Additional studies are needed to further refine optimal treatment strategies for diabetes and SIHD in old age. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Background: The outcomes related to chest pain associated with cocaine use and its burden on the healthcare system are not well studied.Methods: Data were collected from the Nationwide Inpatient Sample (2001-2012). Subjects were identified by using the International Classification of Diseases, Ninth Revision, Clinical Modification codes. Primary outcome was a composite of mortality, myocardial infarction, stroke, and cardiac arrest.Results: We identified 363,143 admissions for cocaine-induced chest pain. Mean age was 44.9 (±21.1) years with male predominance. Left heart catheterizations were performed in 6.7%, whereas the frequency of acute myocardial infarction and percutaneous coronary interventions were 0.69% and 0.22%, respectively. The in-hospital mortality was 0.09%, and the primary outcome occurred in 1.19% of patients. Statistically significant predictors of primary outcome included female sex (odds ratio [OR], 1.16; confidence interval [CI], 1.00-1.35; P = .046), age >50 years (OR, 1.24, CI, 1.07-1.43; P = .004), history of heart failure (OR, 1.63, CI, 1.37-1.93; P <.001), supraventricular tachycardia (OR, 2.94, CI, 1.34-6.42; P = .007), endocarditis (OR, 3.5, CI, 1.50-8.18, P = .004), tobacco use (OR, 1.3, CI, 1.13-1.49; P <.001), dyslipidemia (OR, 1.5, CI, 1.29-1.77; P <.001), coronary artery disease (OR, 2.37, CI, 2.03-2.76; P <.001), and renal failure (OR, 1.27, CI, 1.08-1.50; P = .005). The total annual projected economic burden ranged from $155 to $226 million with a cumulative accruement of more than $2 billion over a decade.Conclusion: Hospital admissions due to chest pain and concomitant cocaine use are associated with low rates of adverse outcomes. For the low-risk cohort in whom acute coronary syndrome has been ruled out, hospitalization may not be beneficial and may result in unnecessary cardiac procedures. [ABSTRACT FROM AUTHOR]

Background: Although human mesenchymal stem cells (hMSCs) have been tested in ischemic cardiomyopathy, few studies exist in chronic nonischemic dilated cardiomyopathy (NIDCM).Objectives: The authors conducted a randomized comparison of safety and efficacy of autologous (auto) versus allogeneic (allo) bone marrow-derived hMSCs in NIDCM.Methods: Thirty-seven patients were randomized to either allo- or auto-hMSCs in a 1:1 ratio. Patients were recruited between December 2011 and July 2015 at the University of Miami Hospital. Patients received hMSCs (100 million) by transendocardial stem cell injection in 10 left ventricular sites. Treated patients were evaluated at baseline, 30 days, and 3-, 6-, and 12-months for safety (serious adverse events [SAE]), and efficacy endpoints: ejection fraction, Minnesota Living with Heart Failure Questionnaire, 6-min walk test, major adverse cardiac events, and immune biomarkers.Results: There were no 30-day treatment-emergent SAEs. Twelve-month SAE incidence was 28.2% with allo-hMSCs versus 63.5% with auto-hMSCs (p = 0.1004 for the comparison). One allo-hMSC patient developed an elevated (>80) donor-specific calculated panel reactive antibody level. The ejection fraction increased in allo-hMSC patients by 8.0 percentage points (p = 0.004) compared with 5.4 with auto-hMSCs (p = 0.116; allo vs. auto p = 0.4887). The 6-min walk test increased with allo-hMSCs by 37.0 m (p = 0.04), but not auto-hMSCs at 7.3 m (p = 0.71; auto vs. allo p = 0.0168). MLHFQ score decreased in allo-hMSC (p = 0.0022) and auto-hMSC patients (p = 0.463; auto vs. allo p = 0.172). The major adverse cardiac event rate was lower, too, in the allo group (p = 0.0186 vs. auto). Tumor necrosis factor-α decreased (p = 0.0001 for each), to a greater extent with allo-hMSCs versus auto-hMSCs at 6 months (p = 0.05).Conclusions: These findings demonstrated safety and clinically meaningful efficacy of allo-hMSC versus auto-hMSC in NIDCM patients. Pivotal trials of allo-hMSCs are warranted based on these results. (Percutaneous Stem Cell Injection Delivery Effects on Neomyogenesis in Dilated Cardiomyopathy [PoseidonDCM]; NCT01392625). [ABSTRACT FROM AUTHOR]

Introduction The effect of acute changes of hemoglobin during index heart failure admission on long-term outcomes remains unknown. Methods We examined 433 patients enrolled in the ESCAPE trial. Results Of the 433 patients, 324 (75%) had baseline and discharge hemoglobin available for analysis. Of those, 64 (20%) had at least 1 g/dL drop of hemoglobin by time of discharge. Compared to patients without hemoglobin changes (g/dL), patients with hemoglobin drop were older (59 vs. 55, p = 0.011), had lower systolic BP (mm Hg) (99 vs. 106, p = 0.017), lower sodium (mg/dL) (136 vs. 137 (mg/dL), p = 0.025), higher BUN (mg/dL) (37 vs. 26, p < 0.001), higher creatinine (mg/dL) (1.6 vs. 1.3, p < 0.001) and higher hospital length of stay (10 days vs. 6 days, p = < 0.001). Higher hemoglobin drop was observed in the pulmonary artery catheter (PACs) (vs. clinical care) randomized arm of the trial (2 g/dL: 10% versus 3%, p = 0.010; 3 g/dL: 5% versus 0%, p = 0.005). After adjustments, a drop of hemoglobin with at least 1 g/dL was associated with increased mortality risk (Adjusted HR 2.38, p = 0.003) and higher hemoglobin concentrations by the time of discharge was associated with lower mortality rate (Adjusted HR 0.79, p = 0.003). PACs insertion was not associated with adverse clinical outcomes by quartiles of % change of hemoglobin. However, PACs use was an independent predictor of hemoglobin drop during heart failure admission (Adjusted OR: Hb Drop 1 g/dL: 1.88, p = 0.043; Hb Drop 2 g/dL: 3.6 p = 0.025). Conclusion In-hospital decrease in hemoglobin is independently associated with increased long-term mortality and hospital length of stay in ADHF. The ideal hemoglobin levels in ADHF patients should be investigated and the insertion of PACs to direct therapy should be weighed against bleeding risks. [ABSTRACT FROM AUTHOR]

Objective: Evaluate the use of mechanical circulatory support (MCS) devices in high-risk patients undergoing transcatheter aortic valve replacement (TAVR).Background: The use of MCS devices in elderly patients with multiple comorbidities undergoing TAVR is underexplored.Methods: All patients undergoing TAVR at a single tertiary academic center who required MCS during index procedure between 2008 and 2015 were included in a prospective database.Results: MCS was used in 9.4% (54/577) of all TAVRs (n = 52 Edwards Sapien and n = 2 CoreValves) of which 68.5% (n = 37) were used as part of a planned strategy, and 31.5% (n = 17) were used in emergency "bail-out" situations. IABP was the most commonly used device (87%) followed by Impella and ECMO (6% each). Among the MCS group, 22% required cardiopulmonary resuscitation during the procedure (n = 4 elective [11%] vs. n = 8 emergent [47%]) and 15% upgrade to a second device (Impella or CPB after IABP; n = 5 elective [14%] vs. n = 3 emergent [18%]). Median duration of support was 1-day. Device related complications were low (4%). In-hospital mortality in this extremely high-risk population was 24% (13/54) (11% [4/37] for elective cases and 53% [9/17] for emergency cases). Cardiogenic shock (50%) was the most common cause of in-hospital death. Cumulative all-cause 1-year mortality was 35% (19/54) (19% 97/370 for elective and 71% [12/17] for emergency cases).Conclusion: Emergent use of MCS during TAVR in extremely high-risk population is associated with high short and long-term mortality rates. Early identification of patients at risk for hemodynamic compromise may rationalize elective utilization of MCS during TAVR. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Introduction Both transfemoral (TF) and transapical (TA) routes are utilized for Transcatheter Aortic Valve Replacement (TAVR) using Edwards SAPIEN & SAPIEN XT valves. We intended to perform a meta-analysis comparing the complication rates between these two approaches in studies published before and after the standardized Valve Academic Research Consortium (VARC) definitions. Methods We performed a comprehensive electronic database search for studies published until January 2014 comparing TF and TA approaches using the Edwards SAPIEN/SAPIEN XT aortic valve. Studies were analyzed based on the following endpoints: 1-year mortality, 30-day mortality, stroke, new pacemaker implantation, bleeding, and acute kidney injury. Results Seventeen studies were included in the meta-analysis. Patients undergoing TA TAVR had a significantly higher logistic EuroSCORE (24.6 ± 12.9 vs. 21.3 ± 12.0; P < 0.001). The cumulative risks for 30-day mortality (RR 0.61; 95%CI 0.46-0.81; P = 0.001), 1-year mortality (RR 0.68; 95%CI 0.55-0.84; P < 0.001), and acute kidney injury (RR 0.53; 95%CI 0.38-0.73; P < 0.001) were significantly lower for patients undergoing TF as compared to TA approach. Both approaches had a similar incidence of 30-day stroke, pacemaker implantation, and major or life-threatening bleeding. Studies utilizing the VARC definitions and those pre-dating VARC yielded similar results. Conclusion This meta-analysis demonstrates a decreased 30-day and 1-year mortality in TF TAVR as compared to TA TAVR. Post-procedure acute kidney injury and the need for renal replacement therapy are also significantly lower in the TF group. These differences hold true even after utilizing the standardized Valve Academic Research Consortium criteria. (J Interven Cardiol 2015;28:266-278) [ABSTRACT FROM AUTHOR]