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Background: Low-density lipoprotein cholesterol (LDL-C) is a well-established risk factor for atherosclerotic cardiovascular disease. However, the optimal achieved LDL-C level with regard to efficacy and safety in the long term remains unknown. Methods: In FOURIER (Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk), 27 564 patients with stable atherosclerotic cardiovascular disease were randomized to evolocumab versus placebo, with a median follow-up of 2.2 years. In the open-label extension (FOURIER-OLE), 6635 of these patients were transitioned to open-label evolocumab regardless of initial treatment allocation in the parent trial and were followed for an additional median of 5 years. In this prespecified analysis, we examined the relationship between achieved LDL-C levels (an average of the first 2 LDL-C levels measured) in FOURIER-OLE (available in 6559 patients) and the incidence of subsequent cardiovascular and safety outcomes. We also performed sensitivity analyses evaluating cardiovascular and safety outcomes in the entire FOURIER and FOURIER-OLE patient population. Multivariable modeling was used to adjust for baseline factors associated with achieved LDL-C levels. Results: In FOURIER-OLE, 1604 (24%), 2627 (40%), 1031 (16%), 486 (7%), and 811 (12%) patients achieved LDL-C levels of P trend Conclusions: In patients with atherosclerotic cardiovascular disease, long-term achievement of lower LDL-C levels, down to Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT01764633.

Understanding the natural history of coronary artery atherosclerosis is necessary to determine prognosis and prescribe effective therapies. Traditional management of coronary artery disease has focused on the treatment of flow-limiting anatomical obstructions that lead to ischaemia. In most scenarios, revascularization of these atherosclerotic plaques has not substantially improved freedom from death or myocardial infarction, questioning the utility of contemporary revascularization strategies to improve prognosis. Advances in non-invasive and invasive imaging techniques have helped to identify the characteristics of obstructive and non-obstructive plaques that are precursors for plaque progression and future acute coronary syndromes as well as cardiac death. These 'vulnerable plaques' develop as a consequence of systemic inflammation and are prone to inducing thrombosis. Vulnerable plaques most commonly have a large plaque burden with a well-formed necrotic core and thin fibrous cap and are metabolically active. Perivascular adipose tissue might, in some patients, be used as a surrogate for coronary inflammation and predict future risk of adverse cardiac events. Vulnerable plaques can be identified in their quiescent state, offering the potential for therapeutic passivation. In this Review, we describe the biological and compositional features of vulnerable plaques, the non-invasive and invasive diagnostic modalities to characterize vulnerable plaques, the prognostic utility of identifying vulnerable plaques, and the future studies needed to explore the value of intensified pharmacological and focal treatments of vulnerable plaques.

REDUCE-IT was a multinational, double-blind trial that randomized 8179 statin-treated patients with controlled low-density lipoprotein cholesterol and moderately elevated triglycerides to icosapent ethyl (IPE) or placebo. IPE was associated with a substantial reduction in the primary composite endpoint of death from cardiovascular causes, nonfatal myocardial infarction, nonfatal stroke, coronary revascularization, or unstable angina requiring hospitalization. Since the original publication of the trial, there have been a myriad of additional analyses confirming the benefit of IPE in various patient groups. Our objectives in this review are to summarize the key findings of the REDUCE-IT trial and its subsequent analyses as well as to call for the reevaluation and expansion of current guidelines to incorporate IPE as a therapy for patients at elevated cardiovascular risk with mild or moderate hypertriglyceridemia.

Introduction: Misinformation, distrust, and other sociocultural factors that influence vaccine uptake may also influence adherence to cholesterol treatment. Hypothesis: Among American adults with hyperlipidemia, individuals who receive influenza vaccination are more likely to report use of cholesterol lowering medication. Methods: We pooled 2017 and 2019 survey data from the Behavioral Risk Factor Surveillance System (BRFSS). Our sample included all respondents aged 40 to 75 years with self-reported high cholesterol. We used logistic regression models adjusted for potential confounders to examine the association between influenza vaccine uptake and use of cholesterol medication. We also evaluated whether the association was different among those with and without established atherosclerotic cardiovascular disease (ASCVD). All analyses accounted for survey weighting. Results: Of 228,338 (weighted = 107,893,277) participants with hyperlipidemia, 51% reported influenza vaccination and 61% reported taking cholesterol medication. Vaccine uptake was associated with cholesterol medication use (OR 2.08, 95% CI 2.00-2.16, p Conclusions: Influenza vaccine uptake is associated with cholesterol medication use among American adults with high cholesterol, including those with ASCVD. The sociocultural factors affecting vaccine avoidance, such as misinformation and distrust, merit investigation as potential targets of cardiovascular prevention efforts.

Prior studies in patients with noncomplex coronary artery disease have demonstrated the safety of percutaneous coronary intervention (PCI) in the outpatient setting. We sought to examine the outcomes of outpatient PCI in patients with unprotected left main coronary artery disease (LMCAD). In the EXCEL trial, 1905 patients with LMCAD and site-assessed low or intermediate SYNTAX scores were randomized to PCI with everolimus-eluting stents versus coronary artery bypass grafting. The primary end point was major adverse cardiovascular events (MACE; the composite of death, stroke, or myocardial infarction). In this sub-analysis, outcomes at 30 days and 5 years were analyzed according to whether PCI was performed in the outpatient versus inpatient setting. Among 948 patients with LMCAD assigned to PCI, 935 patients underwent PCI as their first procedure, including 100 (10.7%) performed in the outpatient setting. Patients who underwent outpatient compared with inpatient PCI were less likely to have experienced recent myocardial infarction. Distal left main bifurcation disease involvement and SYNTAX scores were similar between the groups. Comparing outpatient to inpatient PCI, there were no significant differences in MACE at 30 days (4.0% vs 5.0% respectively, adjusted OR 0.52 95% CI 0.12 to 2.22; p = 0.38) or 5 years (20.6% vs 22.1% respectively, adjusted OR 0.72, 95% CI 0.40 to 1.29; p = 0.27). Similar results were observed in patients with distal left main bifurcation lesions. In conclusion, in the EXCEL trial, outpatient PCI of patients with LMCAD was not associated with an excess early or late hazard of MACE. These data suggest that outpatient PCI may be safely performed in select patients with LMCAD.

Coronary artery disease is the leading cause of morbidity and mortality worldwide. Selected patients with obstructive coronary artery disease benefit from revascularization with percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) surgery. Many (but not all) studies have demonstrated increased survival and greater freedom from adverse cardiovascular events after complete revascularization (CR) than after incomplete revascularization (ICR) in patients with multivessel disease. However, achieving CR after PCI or CABG surgery might not be feasible owing to patient comorbidities, anatomical factors, and technical or procedural considerations. These factors also mean that comparisons between CR and ICR are subject to multiple confounders and are difficult to understand or apply to real-world clinical practice. In this Review, we summarize and critically appraise the evidence linking various types of ICR to adverse outcomes in patients with multivessel disease and stable ischaemic heart disease, non-ST-segment elevation acute coronary syndrome or ST-segment elevation myocardial infarction, with or without cardiogenic shock. In addition, we provide practical recommendations for revascularization in patients with high-risk multivessel disease to optimize their long-term clinical outcomes and identify areas requiring future clinical investigation.

Background The role of dobutamine stress echocardiography (DSE) in the risk stratification of patients undergoing noncardiac surgery in the current era is unclear. The aim of this study was to evaluate the yield of DSE and the additive role of DSE to clinical criteria for preoperative risk stratification of patients undergoing noncardiac surgery. Methods The study included 4,494 patients undergoing DSE ≤90 days before noncardiac surgery. The primary outcome was a composite of postoperative myocardial infarction, cardiac arrest, and all-cause mortality ≤30 days after noncardiac surgery. Results The overall 30-day postoperative cardiac event rate was 2.3%. The mortality rate was 0.9% overall and 0.7% and 1.3% after normal and abnormal results on DSE, respectively. Among clinical variables, the modified Revised Cardiac Risk Index score demonstrated the strongest association with postoperative risk (P Conclusions Baseline and peak-stress findings on preoperative DSE add to the prognostic utility of clinical variables for stratifying cardiac risk after noncardiac surgery.

Background: Women have a higher rate of adverse events after mitral valve surgery. We sought to evaluate whether outcomes after transcatheter edge-to-edge repair intervention by sex have similar trends to mitral valve surgery. Methods: The primary outcome was 1-year major adverse events defined as a composite of all-cause mortality, stroke, and any bleeding in the overall study cohort. Patients who underwent transcatheter edge-to-edge repair for mitral regurgitation with the MitraClip system in the Society of Thoracic Surgery/American College of Cardiology Transcatheter Valve Therapy registry were evaluated. Linked administrative claims from the Centers for Medicare and Medicaid Services were used to evaluate 1-year clinical outcomes. Associations between sex and outcomes were evaluated using a multivariable logistic regression model for in-hospital outcomes and Cox model for 1-year outcomes. Results: From November 2013 to March 2017, 5295 patients, 47.6% (n=2523) of whom were female, underwent transcatheter edge-to-edge repair. Females were less likely to have >1 clip implanted ( P Conclusions: No difference in composite outcome of all-cause mortality, stroke, and any bleeding was observed between females and males. Adjusted 1-year all-cause mortality was lower in females compared with males.

Background Mitral valve (MV) repair or replacement surgery is indicated for a variety of conditions. Although uncommon, damage to the left circumflex (LCx) coronary artery, which courses in close proximity to the MV annulus, is a devastating complication. Case summary This report describes the case of a 63-year-old woman following re-operative MV replacement. Shortly after being transferred to the surgical intensive care unit after MV replacement, her EKG was notable for persistent inferolateral ST-segment elevations and reciprocal ST-segment depressions. Emergency transthoracic echocardiogram revealed a reduced left ventricular ejection fraction of 35–40% and mid to distal lateral wall motion hypokinesis. She was emergently taken to the cardiac catheterization laboratory where coronary angiography demonstrated complete occlusion of her mid LCx artery. She underwent urgent percutaneous coronary intervention of the lesion and was started on dual antiplatelet treatment, anticoagulation for comorbid atrial fibrillation, as well as guideline directed medical therapy with improvement in her EKG changes and cardiac function. Conclusion Prompt diagnosis and recognition of LCx injury is crucial. Management involves immediate percutaneous recanalization or surgical coronary bypass grafting.

REDUCE-IT was a double-blind trial that randomized 8,179 statin-treated patients with controlled low-density lipoprotein cholesterol and moderately elevated triglycerides to icosapent ethyl (IPE) or placebo. There was a significant reduction in the primary endpoint, including death from cardiovascular (CV) causes. The specific impact of IPE among patients with prior myocardial infarction (MI) was unknown.Our goal was to examine the benefit of IPE on ischemic events among patients with prior MI in REDUCE-IT.We performed post hoc analyses of patients with prior MI. The primary endpoint was CV death, MI, stroke, coronary revascularization, or hospitalization for unstable angina. The key secondary endpoint was CV death, MI, or stroke.A total of 3,693 patients had a history of prior MI. The primary endpoint was reduced from 26.1% to 20.2% with IPE vs placebo; HR: 0.74 (95% CI: 0.65-0.85; P = 0.00001). The key secondary endpoint was reduced from 18.0% to 13.3%; HR: 0.71 (95% CI: 0.61-0.84; P = 0.00006). There was also a significant 35% relative risk reduction in total ischemic events (P = 0.0000001), a 34% reduction in MI (P = 0.00009), a 30% reduction in CV death (P = 0.01), and a 20% lower rate of all-cause mortality (P = 0.054), although there was a slight increase in atrial fibrillation. Sudden cardiac death and cardiac arrest were also significantly reduced by 40% and 56%, respectively.Patients with a history of prior MI in REDUCE-IT treated with IPE demonstrated large and significant relative and absolute risk reductions in ischemic events, including CV death. (A Study of AMR101 to Evaluate Its Ability to Reduce Cardiovascular Events in High Risk Patients With Hypertriglyceridemia and on Statin. The Primary Objective is to Evaluate the Effect of 4 g/Day AMR101 for Preventing the Occurrence of a First Major Cardiovascular Event. [REDUCE-IT]; NCT01492361).

ImportanceIn the Cardiovascular Outcomes for People Using Anticoagulation Strategies (COMPASS) trial, there was a significant reduction in the adjudicated primary outcome among patients with stable atherosclerotic vascular disease randomized to dual pathway inhibition (rivaroxaban 2.5 mg twice daily plus aspirin 100 mg daily) vs aspirin monotherapy, but not with rivaroxaban 5 mg twice daily vs aspirin monotherapy. Whether the results are similar without adjudication is unknown.ObjectiveTo examine the impact of dual pathway inhibition (with rivaroxaban plus aspirin) or rivaroxaban monotherapy compared with aspirin monotherapy on investigator-reported CV events and to understand the extent of concordance between investigator-reported and centrally adjudicated clinical events.Design, Setting, and ParticipantsThis is a secondary analysis of the COMPASS trial, an international, double-blind, double-dummy, randomized clinical trial with a 3-by-2 partial factorial design that evaluated participants with stable atherosclerotic vascular disease receiving rivaroxaban plus aspirin, rivaroxaban monotherapy, or aspirin monotherapy. End points were collected by blinded site investigators and adjudicated by a blinded clinical end point committee. Data were analyzed from March 2013 through February 2017.InterventionsParticipants received dual inhibition pathway (2.5 mg rivaroxaban twice daily plus 100 mg aspirin once daily), rivaroxaban monotherapy (5 mg twice daily), or aspirin monotherapy (100 mg once daily).Main Outcomes and MeasuresThe primary efficacy outcome was a composite of cardiovascular (CV) death, stroke, or myocardial infarction (MI). Adjudicated and investigator-reported end points were compared.ResultsA total of 27 395 patients (mean [SD] age, 68.2 [7.9] years; 78.0% men) were assessed, including 9152 patients randomized to dual pathway inhibition, 9117 patients randomized to rivaroxaban monotherapy, and 9126 patients randomized to aspirin monotherapy. Adjudication reduced the number of events by 10% to 15% for most end points. Among investigator-reported end points, dual pathway inhibition significantly reduced the rate of the primary efficacy outcome compared with aspirin alone (411 patients [4.5%] vs 542 patients [5.9%]; hazard ratio [HR], 0.75 [95% CI, 0.66-0.85]; P P P = .04) compared with adjudicated events (448 patients [4.9%] vs 496 patients [5.4%]; HR, 0.90 [95% CI, 0.79-1.03]; P = .12).Conclusions and RelevanceThis secondary analysis of the COMPASS trial found that whether assessed by blinded site investigators or adjudicators, dual pathway inhibition significantly reduced CV events among patients with stable atherosclerotic disease compared with aspirin plus placebo. These findings suggest that using investigator-reported events in blinded clinical trials may be a more efficient alternative to adjudication.Trial RegistrationClinicalTrials.gov Identifier: NCT01776424

Background: The prognostic significance of paced QRS complex morphology on surface ECG remains unclear. This study aimed to assess long-term outcomes associated with variations in the paced QRS complex. Methods: Adult patients who underwent dual-chamber pacemaker implantation with 20% or more ventricular pacing and a 12-lead ECG showing a paced complex were included. The paced QRS was analyzed in leads I and aVL. Long-term clinical and echocardiographic outcomes were compared at 5 years. Results: The study included 844 patients (43.1% female; age 75.0 ± 12.1). Patients with a longer paced QRS (pQRS) duration in lead I had a lower rate of atrial fibrillation (HR 0.80; p = 0.03) and higher rate of systolic dysfunction (HR 1.17; p

REDUCE-IT (Reduction of Cardiovascular Events With Icosapent Ethyl-Intervention Trial) randomized statin-treated patients with elevated triglycerides to icosapent ethyl (IPE) or placebo. There was a significant reduction in adjudicated events, including the primary endpoint (cardiovascular [CV] death, myocardial infarction [MI], stroke, coronary revascularization, unstable angina requiring hospitalization) and key secondary endpoint (CV death, MI, stroke) with IPE.The purpose of this study was to determine the effects of IPE on investigator-reported events.Potential endpoints were collected by blinded site investigators and subsequently adjudicated by a blinded Clinical Endpoint Committee (CEC) according to a prespecified charter. Investigator-reported events were compared with adjudicated events for concordance.There was a high degree of concordance between investigator-reported and adjudicated endpoints. The simple Kappa statistic between CEC-adjudicated vs site-reported events for the primary endpoint was 0.89 and for the key secondary endpoint was 0.90. Based on investigator-reported events in 8,179 randomized patients, IPE significantly reduced the rate of the primary endpoint (19.1% vs 24.6%; HR: 0.74 [95% CI: 0.67-0.81]; P 0.0001) and the key secondary endpoint (10.5% vs 13.6%; HR: 0.75 [95% CI: 0.66-0.85]; P 0.0001). Among adjudicated events, IPE similarly reduced the rate of the primary and key secondary endpoints.IPE led to consistent, significant reductions in CV events, including MI and coronary revascularization, as determined by independent, blinded CEC adjudication as well as by blinded investigator-reported assessment. These results highlight the robust evidence for the substantial CV benefits of IPE seen in REDUCE-IT and further raise the question of whether adjudication of CV outcome trial endpoints is routinely required in blinded, placebo-controlled trials. (Evaluation of the Effect of AMR101 on Cardiovascular Health and Mortality in Hypertriglyceridemic Patients With Cardiovascular Disease or at High Risk for Cardiovascular Disease: REDUCE-IT [Reduction of Cardiovascular Events With EPA - Intervention Trial]; NCT01492361).

Guideline‐based medical therapy is the foundation of treatment for individuals with coronary artery disease. However, revascularization with either percutaneous coronary intervention or coronary artery bypass grafting may be beneficial in patients with acute coronary syndromes, refractory symptoms, or in other specific scenarios (eg, left main disease and heart failure). While the goal of percutaneous coronary intervention and coronary artery bypass grafting is to achieve complete revascularization, anatomical and ischemic definitions of complete revascularization and their methodology for assessment remain highly variable. Such lack of consensus invariably contributes to the absence of standardized approaches for invasive treatment of coronary artery disease. Herein, we propose a novel, comprehensive, yet pragmatic algorithm with both anatomical and ischemic parameters that aims to provide a systematic method to assess complete revascularization after percutaneous coronary intervention or coronary artery bypass grafting in both clinical practice and clinical trials.

Objectives This study sought to assess the sex-specific outcomes in patients with heart failure (HF) with 3+ and 4+ secondary mitral regurgitation (SMR) treated with transcatheter mitral valve repair (TMVr) plus guideline-directed medical therapy (GDMT) versus GDMT alone in the COAPT trial. Background The impact of sex in patients with HF and severe SMR treated with TMVr with the MitraClip compared with GDMT alone is unknown. Methods Patients were randomized 1:1 to TMVr versus GDMT alone. Two-year outcomes were examined according to sex. Results Among 614 patients, 221 (36.0%) were women. Women were younger than men and had fewer comorbidities, but reduced quality of life and functional capacity at baseline. In a joint frailty model accounting for the competing risk of death, the 2-year cumulative incidence of the primary endpoint of all HF hospitalizations (HFH) was higher in men compared with women treated with GDMT alone. However, the relative reduction in HFHs with TMVr was greater in men (HR: 0.43; 95% CI: 0.34-0.54) than women (HR: 0.78; 95% CI: 0.57-1.05) (Pinteraction = 0.002). A significant interaction between TMVr versus GDMT alone treatment and time was present for all HFHs in women (HR: 0.57; 95% CI: 0.39-0.84, and HR: 1.39; 95% CI: 0.83-2.33 between 0-1 year and 1-2 years after randomization, respectively, Pinteraction = 0.007) but not in men (HR: 0.48; 95% CI: 0.36-0.64, and HR: 0.33; 95% CI: 0.21-0.51; Pinteraction = 0.16). Female sex was independently associated with a lower adjusted risk of death at 2 years (HR: 0.64; 95% CI: 0.46-0.90; P = 0.011). TMVr consistently reduced 2-year mortality compared with GDMT alone, irrespective of sex (Pinteraction = 0.99). Conclusions In the COAPT trial, TMVr with the MitraClip resulted in improved clinical outcomes compared with GDMT alone, irrespective of sex. However, the impact of TMVr in reducing HFH was less pronounced in women compared with men beyond the first year after treatment. (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation [The COAPT Tria] [COAPT]; NCT01626079 )

Coronary artery disease is the leading cause of morbidity and mortality worldwide. Selected patients with obstructive coronary artery disease benefit from revascularization with percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) surgery. Many (but not all) studies have demonstrated increased survival and greater freedom from adverse cardiovascular events after complete revascularization (CR) than after incomplete revascularization (ICR) in patients with multivessel disease. However, achieving CR after PCI or CABG surgery might not be feasible owing to patient comorbidities, anatomical factors, and technical or procedural considerations. These factors also mean that comparisons between CR and ICR are subject to multiple confounders and are difficult to understand or apply to real-world clinical practice. In this Review, we summarize and critically appraise the evidence linking various types of ICR to adverse outcomes in patients with multivessel disease and stable ischaemic heart disease, non-ST-segment elevation acute coronary syndrome or ST-segment elevation myocardial infarction, with or without cardiogenic shock. In addition, we provide practical recommendations for revascularization in patients with high-risk multivessel disease to optimize their long-term clinical outcomes and identify areas requiring future clinical investigation.

The COVID-19 pandemic has provided the vital stepping stones to improve how clinical trials are conducted. We provide an overview of the major changes to the clinical trial process instigated by the pandemic and suggest ways to make these changes sustainable.

Background Right bundle‐branch block (RBBB) occurs in 0.2% to 1.3% of people and is considered a benign finding. However, some studies have suggested increased risk of cardiovascular morbidity and mortality. We sought to evaluate risk attributable to incidental RBBB in patients without prior diagnosis of cardiovascular disease (CVD). Methods and Results We reviewed the Mayo Clinic Integrated Stress Center database for exercise stress tests performed from 1993 to 2010. Patients with no known CVD—defined as absence of coronary disease, structural heart disease, heart failure, or cerebrovascular disease—were selected. Only Minnesota residents were included, all of whom had full mortality and outcomes data. There were 22 806 patients without CVD identified; 220 of whom (0.96%) had RBBB, followed for 6 to 23 years (mean 12.4±5.1). There were 8256 women (36.2%), mean age was 52±11 years; and 1837 deaths (8.05%), including 645 cardiovascular‐related deaths (2.83%), occurred over follow‐up. RBBB was predictive of all‐cause (hazard ratio [HR], 1.5; 95% CI, 1.1–2.0; P =0.0058) and cardiovascular‐related mortality (HR,1.7; 95% CI, 1.1–2.8; P =0.0178) after adjusting for age, sex, diabetes mellitus, hypertension, obesity, current and past history of smoking, and use of a heart rate‐lowering drug. Patients with RBBB exhibited more hypertension (34.1% versus 23.7%, P P P P Conclusions Patients with RBBB without CVD have increased risk of all‐cause mortality, cardiovascular‐related mortality, and lower exercise tolerance. These data suggest RBBB may be a marker of early CVD and merit further prospective evaluation.

This study describes demographic characteristics and hospital bed capacities of the 5 New York City boroughs, and evaluates whether differences in testing for coronavirus disease 2019 (COVID-19), hospitalizations, and deaths have emerged as a signal of racial, ethnic, and financial disparities.

Objectives We aimed to develop a percutaneous defibrillation system with partially insulated epicardial coils to focus electrical energy on the myocardium and prevent or minimize extracardiac stimulation. Background Epicardial defibrillation systems currently require surgical access. Methods We tested 2 prototypes created for percutaneous introduction into the pericardial space via a steerable sheath. This testing included a partially insulated defibrillation coil and a defibrillation mesh with a urethane balloon acting as an insulator to the face of the mesh not in contact with the epicardium. The average energy associated with a chance of successful defibrillation 75% of the time was calculated for each experiment. Results Of 16 animal experiments, 3 pig experiments had malfunctioning mesh prototypes such that results were unreliable; these were excluded. Therefore, 13 animal experiments were analyzed, 6 in canines (29.8 ± 4.0 kg) and 7 in pigs (41.1 ± 4.4 kg). The overall chance of successful defibrillation 75% of the time was 12.8 ± 6.7 J (10.9 ± 9.1 J for canines and 14.4 ± 3.9 J in pigs; p = 0.37). The lowest chance of successful defibrillation 75% of the time obtained in canines was 2.5 J, whereas in pigs it was 9.5 J. The lowest energy resulting in successful defibrillation was 2 J in canines and 5 J in pigs. There was no evidence of coronary vessel injury or trauma to extrapericardial structures. Conclusions Percutaneous, epicardial defibrillation using a partially insulated coil is feasible and seems to be associated with low defibrillation thresholds. Focusing insulation may limit extracardiac stimulation and potentially lower energy requirements for efficient defibrillation.

Anemia is an independent predictor of mortality, major adverse cardiovascular events (MACE), and bleeding after percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG) surgery ([1–3][1]). The relationship between pre-existing anemia and revascularization outcomes in

Introduction Epicardial procedures frequently require pericardial manipulation. We aimed to develop a nonsurgical percutaneous pericardial modification tool that may (1) facilitate epicardial-based procedures by enabling adhesiolysis or (2) attenuate the myocardial constraining effect of the pericardium. Methods Three novel devices were developed to enable pericardiotomy, all of which can be deployed in over-the-wire fashion following percutaneous epicardial access. The grasper permits us to seize the pericardial membrane providing leverage for incision. The scissors enables anterograde cutting maneuvers. The reverse-slitter allows retrograde incisions; in addition, this device has a deflectable tip that increases the potential cutting area. We optimized these tools for safety by including electrodes to test for phrenic nerve stimulation as well as myocardial stimulation to determine directionality of the cutting devices. The base of the scissors and reverse-slitter are also blunt ensuring that the cutting element is always away from the myocardium. Results Following 5 non-beating heart bench test experiments for prototype development, 11 animal (9 canine, 2 swine) studies were performed. Of these 2 were proof-of-concept open chest studies; the remaining 9 were entirely closed-chest, percutaneous procedures allowing for re-modification of the prototypes. The tools successfully permitted incision of the pericardium in all studies. Hemodynamic measurements were assessed post-incision and showed no compromise of systolic function. No coronary artery or phrenic nerve damage was seen in any study. Conclusion Percutaneous pericardiotomy is feasible and appears to be safe. It may provide leverage in epicardial-based procedures and offer treatment options in disease processes characterized by pericardial restraint. This article is protected by copyright. All rights reserved

BACKGROUND The association of atypical nevi with melanoma and other forms of skin cancer has not been clearly defined. METHODS We studied 631 patients with first lifetime diagnosis of mild, moderate or severely atypical nevus from 2000 through 2005, identified through a population-based approach. RESULTS Age at first diagnosis differed significantly between men and women (p

Background: Right ventricular systolic dysfunction (RVD) often coexists with various cardiopulmonary diseases. However, the association between RVD and risk of sudden cardiac death (SCD) has not been well studied. This study examined the risk of SCD associated with RVD in patients with heterogeneous underlying cardiac diseases. Methods: The Mayo Clinic cardiac care unit database included 5463 consecutive patients with complete echocardiographic evaluation to assess right ventricular systolic function and RVD severity. Prospective surveillance follow-up was obtained for all patients. SCD was adjudicated when a malignant ventricular arrhythmia was documented as the primary rhythm leading to death. RESULTS: The prevalence of mild RVD and moderate-severe RVD was 14.9% and 17.1%, respectively. Patients with RVD were more likely to have a history of congestive heart failure, cardiac arrest, pulmonary disease, and lower baseline left ventricular ejection fraction compared with those with normal right ventricular systolic function. During a median follow-up of 14 months, the incidence of SCD was highest in patients with moderate-severe RVD (7.4% versus 4.4% in mild RVD versus 1.6% in normal right ventricular function; P P =0.046) and moderate-severe RVD (adjusted hazard ratio, 1.91; P =0.006) were independently associated with an increased risk of SCD. Moderate-severe RVD remained an independent predictor of SCD for patients with left ventricular ejection fraction >35% without or with preexisting implantable cardioverter-defibrillator (adjusted hazard ratio, 4.12; P =0.003 and adjusted hazard ratio, 5.04; P Conclusions: Presence of RVD in patients with a history of preexisting cardiac disease is an independent predictor of SCD irrespective of left ventricular ejection fraction.

To demonstrate the feasibility of directional percutaneous epicardial ablation using a partially insulated catheter. Partially insulated catheter prototypes were tested in 12 (6 canine, 6 porcine) animal studies in two centers. Prototypes had interspersed windows to enable visualization of epicardial structures with ultrasound. Epicardial unipolar ablation and ablation between two electrodes was performed according to protocol (5–60 W power, 0–60 mls/min irrigation, 78 s mean duration). Of 96 epicardial ablation attempts, unipolar ablation was delivered in 53.1%. Electrogram evidence of ablation, when analyzable, occurred in 75 of 79 (94.9%) therapies. Paired pre/post-ablation pacing threshold (N = 74) showed significant increase in pacing threshold post-ablation (0.9 to 2.6 mA, P

Little is known about safety of antipsychotic therapy for delirium in the coronary care unit (CCU). Our aim was to examine the effect of delirium and antipsychotic therapy among CCU patients.Pre-study Confusion Assessment Method-Intensive Care Unit (CAM-ICU) criteria were implemented in screening consecutive patients admitted to a referral CCU from 2004-2013. Death status was prospectively ascertained. Of 11,079 study patients, the incidence of delirium was 8.3% ( n=925). Delirium was associated with an increased risk of in-hospital mortality (adjusted odds ratio (OR) 1.49; 95% confidence interval (CI), 1.08-2.08; p=0.02) and one-year mortality among patients who survived from CCU admission (adjusted hazard ratio (HR) 1.46; 95% CI, 1.12-1.87; p=0.005). A total of 792 doses of haloperidol (5 mg/day; interquartile range (IQR) 3-10) or quetiapine (25 mg/day; IQR 13-50) were given to 244 patients with delirium. The clinical characteristics of patients with delirium who did and did not receive antipsychotic therapy were not different (baseline corrected QT (QTc) interval 457±58 ms vs 459±60 ms, respectively; p=0.65). In comparison to baseline, mean QTc intervals after the first and third doses of the antipsychotics were not significantly prolonged in haloperidol (448±56, 458±57 and 450±50 ms, respectively) or quetiapine groups (470±66, 467±68 and 462±46 ms, respectively) ( p0.05 for all). Additionally, in-hospital mortality (adjusted OR 0.67; 95% CI, 0.42-1.04; p=0.07), ventricular arrhythmia (adjusted OR 0.87; 95% CI, 0.17-3.62; p=0.85) and one-year mortality among the hospital survivors (adjusted HR 0.86; 95% CI 0.62-1.17; p=0.34) were not different in patients with delirium irrespective of whether or not they received antipsychotics.In patients admitted to the CCU, delirium was associated with an increase in both in-hospital and one-year mortality. Low doses of haloperidol and quetiapine appeared to be safe, without an increase in risk of sudden cardiac death, in-hospital mortality, or one-year mortality in carefully monitored patients.

The use of progressive tension sutures alone has been shown to be comparable to using abdominal drains in aesthetic abdominoplasty. This study reviews outcomes with the use of barbed progressive tension suture technique without drains in DIEP donor site closure compared to standard closure with drains.A two year retrospective review was conducted of DIEP flap reconstructions in the enhanced recovery program at Mayo Clinic, Rochester (USA). Donor site closure was divided into barbed progressive tension sutures (B-PTS) without drains, and standard abdominal closure with drains(S-AD). Demographics, perioperative data and donor site complications were documented.93 patients were included in the study, 42 in the B-PTS no drain group and 51 in the S-AD with drains. 81% of all procedures were bilateral and 39% were immediate. Patients were discharged faster to the ward postoperatively and total hospital admission was reduced in the B-PTS group, 3.7 (SD = 1.4) days versus 4.7 (SD = 2.1) days in the standard group (P = 0 0.001 and 0.004 respectively). Less morphine was required postoperative day (POD) 1, 2 and 3 (P = 0.04, 0.03, 0.02 respectively), and time to mobilize was quicker but not statistically significant (P = 0.09) in the B-PTS group. Overall there were 18 patients in the S-AD group who had complications versus 9 in the B-PTS group (P = 0.14). The incidence of complications occurring within 30 days were lower in the B-PTS group (P = 0.05). The overall seroma rate was 5.4% and rates in the B-PTS group was 2.4% versus 7.8% in the S-AD group, P = 0.37.Use of barbed progressive tension sutures for abdominal closure after DIEP flap harvest can obviate the need for abdominal drains, reduce postoperative pain and encourage early discharge from the hospital without an increased risk in complications.III.

Over 5 million individuals are afflicted with heart failure in the United States per year. Current guidelines based on the MADIT- I and II, MUSTT and SCDHeFT trials recommend the use of pharmacologic as well as implantable cardioverter defibrillator (ICD) therapy as Class I indications for the prevention of sudden cardiac death (SCD) in a subgroup of patients (depending on their ejection fraction, NYHA class, and a variety of other parameters). However, despite these guidelines, the use of ICDs has been reported as suboptimal in prior publications as well as in the article by Pillarisetti, et al in this issue of the Journal .

Ventricular arrhythmia arising from the outflow tracts can manifest itself as frequent premature ventricular complexes (PVCs), salvos of ventricular tachycardia (VT), and/or sustained VT. It is amenable to management with medication and catheter ablation without need for an intracardiac defibrillator. The electrocardiogram (ECG) is a crucial tool in the management of these patients as it is can help localize the site of origin, thereby helping guide the electrophysiologist. An appreciation of the unique anatomy of the outflow tracts as well as their relationships with the surrounding structures is essential in interpreting the ECG. In this review, we examine the ECG features of the various outflow tract arrhythmia morphologies with a focus on anatomy and provide an approach to the ablation of these abnormal rhythms.

Background— People with heart failure and preserved ejection fraction develop increases in left ventricular (LV) end-diastolic pressures during exercise that contribute to dyspnea. In normal open-chest animal preparations, the pericardium restrains LV filling when central blood volume increases. We hypothesized that resection of the pericardium using a minimally invasive epicardial approach would mitigate the increase in LV end-diastolic pressure that develops during volume loading in normal and diseased hearts with the chest intact. Methods and Results— Invasive hemodynamic assessment was performed at baseline and after saline load before and after pericardial resection in normal canines with open (n=3) and closed chest (n=5) and in a pig model with features of human heart failure and preserved ejection fraction with sternum intact (n=4). In closed-chest animals, pericardiotomy was performed using a novel subxiphoid procedure. In both experimental preparations of normal dogs, pericardiotomy blunted the increase in LV end-diastolic pressure with saline infusion, while enhancing the saline-mediated increase in LV end-diastolic volume. With chest intact in the pig model, percutaneous pericardial resection again blunted the increase in LV end-diastolic pressure secondary to volume expansion (+4±3 versus +13±5 mm Hg; P =0.014), while enhancing the saline-mediated increase in LV end-diastolic volume (+17±1 versus +10±2 mL; P =0.016). Conclusions— This proof of concept study demonstrates that pericardial resection through a minimally invasive percutaneous approach mitigates the elevation in LV filling pressures with volume loading in both normal animals and a pig model with diastolic dysfunction. Further study is warranted to determine whether this method is safe and produces similar acute and chronic hemodynamic benefits in people with heart failure and preserved ejection fraction.

Prakriti Gaba, BS, J. Martijn Bos, MD, PhD, Maully J. Shah, MBBS, Michael J. Ackerman, MD, PhD From the Mayo Medical School, Mayo Clinic, Rochester, Minnesota, Department of Pediatric and Adolescent Medicine/Division of Pediatric Cardiology, Mayo Clinic, Rochester, Minnesota, The Cardiac Center, The Children’s Hospital of Philadelphia, Philadelphia, Pennsylvania, Department of Medicine/ Division of Cardiovascular Diseases, Mayo Clinic, Rochester, Minnesota, and Department of Molecular Pharmacology & Experimental Therapeutics, Windland Smith Rice Sudden Death Genomics Laboratory, Mayo Clinic, Rochester, Minnesota.

Baseline anemia is a strong predictor of adverse events after coronary revascularization. Whether baseline anemia should guide selection of PCI vs. CABG in pts with left main CAD (LMCAD) is unknown. In the EXCEL trial, 1905 pts with LMCAD and low/intermediate SYNTAX scores were randomized to PCI vs

Prior studies of patients with noncomplex coronary artery disease have demonstrated safety of percutaneous coronary intervention (PCI) performed in the outpatient setting. The angiographic finding of left main coronary artery disease (LMCAD) usually prompts hospital admission for rapid

Patients undergoing revascularization for left main coronary artery disease (LMCAD) may develop non–periprocedural-related myocardial infarction (MI) during long-term follow-up. There is limited information regarding the relative rate and prognostic impact of such spontaneous MI after percutaneous

Epicardial cardiac resynchronization therapy (CRT) permits unrestricted electrode positioning. However, this requires surgical placement of device leads and the risk of unwanted phrenic nerve stimulation. We hypothesized that shielded electrodes can capture myocardium without extracardiac stimulation.In 6 dog and 5 swine experiments, we used a percutaneous approach to access the epicardial surface of the heart, and deploy novel leads housing multiple electrodes with selective insulation. Bipolar pacing thresholds at prespecified sites were tested compare electrode threshold data both facing towards and away from the epicardial surface.In 151 paired electrode recordings (70 in 6 dogs; 81 in 5 swine), thresholds facing myocardium were lower than facing away (median [IQR] mA: dogs 0.9 [0.4-1.6] vs 4.6 [2.1 to10], p0.0001; swine 0.5 [0.2-1] vs 2.5 [0.5-6.8], p0.0001). Myocardial capture was feasible without extracardiac stimulation at all tested sites, with mean ± SE threshold margin 3.6±0.7 mA at sites of high output extracardiac stimulation (p=0.004).Selective electrode insulation confers directional pacing to a multielectrode epicardial pacing lead. This device has the potential for a novel percutaneous epicardial resynchronization therapy that permits placement at an optimal pacing site, irrespective of the anatomy of the coronary veins or phrenic nerves.