Factors influencing the indication of coronary angiography in patients presenting with chest pain unspecified: an analysis of two decades (1994-2014).

Guidelines for cardiac catheterization in patients with non-specific chest pain (NSCP) provide significant room for provider discretion, which has resulted in variability in the utilization of invasive coronary angiograms (CAs) and a high rate of normal angiograms. The overutilization of CAs in patients with NSCP and discharged without a diagnosis of coronary artery disease is an important issue in medical care quality. As a result, we sought to identify patient demographic, socioeconomic, and geographic factors that influenced the performance of a CA in patients with NSCP who were discharged without a diagnosis of coronary artery disease. We intended to establish reference data points for gauging the success of new initiatives for the evaluation of this patient population. In this 20-year retrospective cohort study (1994-2014), we examined 107 796 patients with NSCP from the Myocardial Infarction Data Acquisition System, a large statewide validated database that contains discharge data for all patients with cardiovascular disease admitted to every non-federal hospital in NJ. Patients were partitioned into two groups: those offered a CA (CA group; n = 12 541) and those that were not (No-CA group; n = 95 255). Geographic, demographic, and socioeconomic variables were compared between the two groups using multivariable logistic regression, which determined the predictive value of each categorical variable on the odds of receiving a CA. Whites were more likely than Blacks and other racial counterparts (19.7% vs. 5.6% and 16.5%, respectively; P < .001) to receive a CA. Geographically, patients who received a CA were more likely admitted to a large hospital compared to small- or medium-sized ones (12.5% vs. 8.9% and 9.7%, respectively; P < .05), a primary teaching institution rather than a teaching affiliate or community center (16.1 % vs. 14.3% and 9.1%, respectively; P < .001), and at a non-rural facility compared to a rural one (12.1% vs. 6.5%; P < .001). Lastly from a socioeconomic standpoint, patients with commercial insurance more often received a CA compared to those having Medicare or Medicaid/self-pay (13.7% vs. 9.5% and 6.0%, respectively; P < .001). The utilization of CA in patients with NSCP discharged without a diagnosis of coronary artery disease in NJ during the study period may be explained by differences in geographic, demographic, and socioeconomic factors. Patients with NSCP should be well scrutinized for CA eligibility, and reliable strategies are needed to reduce discretionary medical decisions and improve quality of care.

Multivariate survival analysis in big data: A divide-and-combine approach.

Multivariate failure time data are frequently analyzed using the marginal proportional hazards models and the frailty models. When the sample size is extraordinarily large, using either approach could face computational challenges. In this paper, we focus on the marginal model approach and propose a divide-and-combine method to analyze large-scale multivariate failure time data. Our method is motivated by the Myocardial Infarction Data Acquisition System (MIDAS), a New Jersey statewide database that includes 73,725,160 admissions to nonfederal hospitals and emergency rooms (ERs) from 1995 to 2017. We propose to randomly divide the full data into multiple subsets and propose a weighted method to combine these estimators obtained from individual subsets using three weights. Under mild conditions, we show that the combined estimator is asymptotically equivalent to the estimator obtained from the full data as if the data were analyzed all at once. In addition, to screen out risk factors with weak signals, we propose to perform the regularized estimation on the combined estimator using its combined confidence distribution. Theoretical properties, such as consistency, oracle properties, and asymptotic equivalence between the divide-and-combine approach and the full data approach are studied. Performance of the proposed method is investigated using simulation studies. Our method is applied to the MIDAS data to identify risk factors related to multivariate cardiovascular-related health outcomes.

Does One's Socioeconomic Status Predispose to the Development of Stress-Induced Cardiomyopathy?

INTRODUCTION: Stress-induced cardiomyopathy (SIC) has a higher incidence in Caucasians (CAUCs) compared to African-Americans (AAs). Whether this is due to racial predisposition, selection bias, or environmental factors remains unclear. HYPOTHESIS: We hypothesize that people from lower socioeconomic strata (SES) have a lower incidence of SIC. It is possible that the incidence of SIC could be similar among CAUCs and AAs at the same SES. Stress preconditioning maybe protective in preventing SIC. METHODS: Data of patients with the discharge diagnosis of SIC were extracted from the Myocardial Infarction Data Acquisition System spanning the period from 2006 through 2015. The incidence of SIC among CAUCs and AAs was compared per 100,000 New Jersey population and examined across income brackets. CAUCs and AAs data were compared using two-sample proportion tests. RESULTS: During the study period, CAUCs had an overall higher incidence of SIC compared to AAs, 0.017% versus 0.0084% per 100,000 population (p value <0.0001). This difference persisted after a logistic regression adjustment (p = 0.0064). CAUCs in the income brackets of 30-40k had lower incidence of SIC than those in the 60-80k income bracket (p = 0.0156). Those with an income of 60-80k had lower incidence of SIC compared to those with an income of 80-100k. AAs with income between 30 and 60k had a lower incidence of SIC than CAUCs (p = 0.0330). CONCLUSIONS: CAUCs exhibited a trend towards less SIC as a function of lower income. This was not observed among AAs. AAs had a lower incidence of SIC. Our study suggests that SES has a protective effect among CAUCs.

Stroke Recovery Program with Modified Cardiac Rehabilitation Improves Mortality, Functional & Cardiovascular Performance.

BACKGROUND: Physical activity and exercise after stroke is strongly recommended, providing many positive influences on function and secondary stroke prevention. The purpose of this study was to investigate the effect of a stroke recovery program (SRP) integrating modified cardiac rehabilitation on mortality and functional outcomes for stroke survivors. METHODS: This study used a retrospective analysis of data from a prospectively collected stroke rehabilitation database which followed 449 acute stroke survivors discharged from an inpatient rehabilitation facility between 2015 and 2020. For 1-year post-stroke, 246 SRP-participants and 203 nonparticipants were compared. The association of the SRP including modified cardiac rehabilitation with all-cause mortality and functional performance was assessed using the following statistical techniques: log rank test, Cox proportional hazard model and linear mixed effect models. Cardiovascular performance over 36 sessions of modified cardiac rehabilitation was assessed using linear effect model with Tukey procedure. The primary outcome measure was 1-year all-cause mortality rate. Secondary outcomes were functional performance measured in Activity Measure of Post-Acute Care scores and cardiovascular performance measured in metabolic equivalent of tasks times minutes. RESULTS: The SRP-participants had: (1) a significantly reduced 1-year post-stroke mortality rate from hospital admission corresponding to a four-fold reduction in mortality (P = 0.005, CI for risk ratio = [0.08, 0.71]), (2) statistically and clinically significant improvement of function in all Activity Measure of Post-Acute Care domains (P < 0.001 for all, 95% CI for differences in Basic Mobility [5.9, 10.1], Daily Activity [6.2, 11.8], and Applied Cognitive [3.0, 6.8]) compared to the matched cohort and (3) an improvement in cardiovascular performance over 36 sessions with an increase of 78% metabolic equivalent of tasks times minutes (P < 0.001, 95% CI [70.6, 85.9%]) compared to baseline. CONCLUSIONS: Stroke survivors who participated in a comprehensive stroke recovery program incorporating modified cardiac rehabilitation had decreased all-cause mortality, improved overall function, and improved cardiovascular performance.

A Simple Scoring Tool to Predict Medical Intensive Care Unit Readmissions Based on Both Patient and Process Factors.

BACKGROUND: Although many predictive models have been developed to risk assess medical intensive care unit (MICU) readmissions, they tend to be cumbersome with complex calculations that are not efficient for a clinician planning a MICU discharge. OBJECTIVE: To develop a simple scoring tool that comprehensively takes into account not only patient factors but also system and process factors in a single model to predict MICU readmissions. DESIGN: Retrospective chart review. PARTICIPANTS: We included all patients admitted to the MICU of Robert Wood Johnson University Hospital, a tertiary care center, between June 2016 and May 2017 except those who were < 18 years of age, pregnant, or planned for hospice care at discharge. MAIN MEASURES: Logistic regression models and a scoring tool for MICU readmissions were developed on a training set of 409 patients, and validated in an independent set of 474 patients. KEY RESULTS: Readmission rate in the training and validation sets were 8.8% and 9.1% respectively. The scoring tool derived from the training dataset included the following variables: MICU admission diagnosis of sepsis, intubation during MICU stay, duration of mechanical ventilation, tracheostomy during MICU stay, non-emergency department admission source to MICU, weekend MICU discharge, and length of stay in the MICU. The area under the curve of the scoring tool on the validation dataset was 0.76 (95% CI, 0.68-0.84), and the model fit the data well (Hosmer-Lemeshow p = 0.644). Readmission rate was 3.95% among cases in the lowest scoring range and 50% in the highest scoring range. CONCLUSION: We developed a simple seven-variable scoring tool that can be used by clinicians at MICU discharge to efficiently assess a patient's risk of MICU readmission. Additionally, this is one of the first studies to show an association between MICU admission diagnosis of sepsis and MICU readmissions.

Effect of Intensive vs Standard Blood Pressure Treatment Upon Erectile Function in Hypertensive Men: Findings From the Systolic Blood Pressure Intervention Trial.

INTRODUCTION: The effect of intensive blood pressure control upon erectile function in men with hypertension, but without diabetes, is largely unknown. AIM: To examine the effects of intensive systolic blood pressure (SBP) lowering on erectile function in a multiethnic clinical trial of men with hypertension. METHODS: We performed subgroup analyses from the Systolic Blood Pressure Intervention Trial ([SPRINT]; ClinicalTrials.gov: NCT120602, in a sample of 1255 men aged 50 years or older with hypertension and increased cardiovascular disease risk. Participants were randomly assigned to an intensive treatment group (SBP goal of <120 mmHg) or a standard treatment group (SBP goal of <140 mmHg). MAIN OUTCOME MEASURE: The main outcome measure was change in erectile function from baseline, using the 5-item International Index of Erectile Function (IIEF-5) total score, and erectile dysfunction ([ED]; defined as IIEF-5 score ≤21) after a median follow-up of 3 years. RESULTS: At baseline, roughly two-thirds (66.1%) of the sample had self-reported ED. At 48 months after randomization, we determined that the effects of more intensive blood pressure lowering were significantly moderated by race-ethnicity (p for interaction = 0.0016), prompting separate analyses stratified by race-ethnicity. In non-Hispanic whites, participants in the intensive treatment group reported slightly, but significantly better change in the IIEF-5 score than those in the standard treatment group (mean difference = 0.67; 95% CI = 0.03, 1.32; P = 0.041). In non-Hispanic blacks, participants in the intensive group reported slightly worse change in the IIEF-5 score than those in the standard group (mean difference = -1.17; 95% CI = -1.92, -0.41; P = 0.0025). However, in non-Hispanic whites and non-Hispanic blacks, further adjustment for the baseline IIEF-5 score resulted in nonsignificant differences (P > 0.05) according to the treatment group. In Hispanic/other participants, there were no significant differences in change in the IIEF-5 score between the two treatment groups (P = 0.40). In a subgroup of 280 participants who did not report ED at baseline, the incidence of ED did not differ in the two treatment groups (P = 0.53) and was without interaction by race-ethnicity. CLINICAL IMPLICATIONS: The effect of intensive treatment of blood pressure on erectile function was very small overall and likely not of great clinical magnitude. STRENGTH & LIMITATIONS: Although this study included a validated measure of erectile function, testosterone, other androgen, and estrogen levels were not assessed. CONCLUSION: In a sample of male patients at high risk for cardiovascular events but without diabetes, targeting a SBP of less than 120 mm Hg, as compared with less than 140 mm Hg, resulted in statistically significant effects on erectile function that differed in accordance with race-ethnicity, although the clinical importance of the differences may be of small magnitude. Foy CG, Newman JC, Russell GB, et al. Effect of Intensive vs Standard Blood Pressure Treatment Upon Erectile Function in Hypertensive Men: Findings From the Systolic Blood Pressure Intervention Trial. J Sex Med 2020;17:238-248.

Recurrent Stroke Reduction with Patent Foramen Ovale Closure versus Medical Therapy Based on Patent Foramen Ovale Characteristics: A Meta-Analysis of Randomized Controlled Trials.

Efficacy of patent foramen ovale (PFO) closure in patients with cryptogenic stroke remains a matter of debate. We performed a comprehensive meta-analysis of available randomized controlled trials (RCTs) to evaluate the efficacy and safety of PFO closure versus medical therapy (MT) based on PFO characteristics. Random-effects meta-analysis was conducted to estimate risk ratio (RR) with 95% confidence intervals (CI) for the primary end points of stroke. After systematic search, six RCTs (3,747 patients) with 1,889 patients randomized to PFO closure and 1,858 patients randomized to the MT group were included in the meta-analysis. Overall, PFO closure was associated with a significant reduction in recurrent stroke compared to MT [RR 0.41; 95% CI 0.20-0.83]. While there were no differences in mortality or major bleeding between the two groups, risk of newly diagnosed atrial fibrillation was higher in the PFO closure group compared to MT [RR 5.29; 95% CI 2.32-12.06]. Further, risk reduction in stroke with PFO closure was significant in patients with high-risk PFO characteristics [RR 0.37; 95% CI 0.16-0.87] but not in low-risk patients [RR 0.73; 95% CI 0.29-1.84]. In conclusion, among patients with cryptogenic stroke, PFO closure is associated with a significantly reduced risk of recurrent stroke compared to MT. Additionally, the benefit of PFO closure might be dependent on certain PFO characteristics.

ACE Inhibitor-Induced Angioedema: a Review.

PURPOSE OF REVIEW: This study aims to examine current knowledge on the occurrence, pathophysiology, and treatment of angioedema among patients who receive angiotensin-converting enzyme inhibitors. RECENT FINDINGS: Angiotensin-converting enzyme inhibitors (ACE-I), a medication class used by an estimated 40 million people worldwide, are associated with angioedema that occurs with incidence ranging from 0.1 to 0.7%. The widespread use of ACE-I resulted in one third of all emergency department visits for angioedema. Angioedema occurs more frequently in African Americans, smokers, women, older individuals, and those with a history of drug rash, seasonal allergies, and use of immunosuppressive therapy. The pathophysiology of ACE-I-induced angioedema involves inhibition of bradykinin and substance P degradation by ACE (kininase II) leading to vasodilator and plasma extravasation. Treatment modalities include antihistamines, steroids, and epinephrine, as well as endotracheal intubation in cases of airway compromise. Patients with a history of ACE-I-induced angioedema should not be re-challenged with this class of agents, as there is a relatively high risk of recurrence. CONCLUSION: ACE-I are frequently used therapeutic agents that are associated with angioedema. Their use should be avoided in high-risk individuals and early diagnosis, tracheal intubation in cases of airway compromise, and absolute avoidance of re-challenge are important.

Quality of Meta-Analyses for Randomized Trials in the Field of Hypertension: an Updated and Improved Systematic Review.

Publications of hypertension-related meta-analyses (MAs) have increased exponentially in the past 25 years and now average 8/month. Theoretically, this is facilitating evidence-based management of patients. However, some practitioners and authors of guidelines have questioned the quality of published MAs. By extending a prior review, we have assessed the quality of 212 hypertension-related meta-analyses over 5 years based on systematically searching three computerized libraries. Seventeen criteria grouped into four domains of quality yielded the following results: (1) Assessment of trial quality was accomplished in 89% of MAs, and 38% analyzed trials in subgroups of trial quality where appropriate. (2) All three measures of heterogeneity (I 2, tau, and P for heterogeneity) were reported in 36%, reflecting the failure to report tau, the standard deviation of the main effect. (3) Publication bias was assessed in 75%, and 43% of MAs used a statistical test for publication bias. (4) Regarding transparency, 9 to 31% of MAs reported problems in the previous three domains in the article's abstract. Journal impact factor reporting the MAs declined significantly over 5 years. The percent with criteria of quality in a MA was modestly correlated with journal impact factor (R 2 = 0.05, P = 0.001). False-positive results from inappropriate application of the DerSimonian-Laird model affected 25% of articles, which reported these false positives in the article's abstract in 72%. No more than 25% of MAs had 67% or more of the criteria of quality. In conclusion, skepticism of hypertension-related MAs is justified, but their quality can be readily corrected.

Clinical Application of Biomarkers in Heart Failure with a Preserved Ejection Fraction: A Review.

Heart failure with a preserved ejection fraction (HFpEF) is increasingly prevalent and a leading cause of morbidity and mortality worldwide. HFpEF has a complex pathophysiology, with recent evidence suggesting that an interaction of cardiovascular and noncardiovascular comorbidities (e.g. obesity, hypertension, diabetes, coronary artery disease, and chronic kidney disease) induces an inflammatory state that eventually leads to myocardial structural and functional alterations. Current ACCF/AHA guidelines suggest incorporation of biomarkers along with clinical and imaging tools to establish the diagnosis and disease severity in heart failure (HF). However, the majority of data on biomarkers relating to their levels, or their role in accurate diagnosis, prognostication, and disease activity, has been derived from studies in undifferentiated HF or HF with a reduced EF (HFrEF). As the understanding of the mechanisms underlying HFpEF continues to evolve, biomarkers reflecting different pathways including neurohormonal activation, myocardial injury, inflammation, and fibrosis have a clinical utility beyond the diagnostic scope. Accordingly, in this review article we describe the various established and novel plasma biomarkers and their emerging value in diagnosis, prognosis, response, and guiding of targeted therapy in patients with HFpEF.

Intensive vs Standard Blood Pressure Control and Cardiovascular Disease Outcomes in Adults Aged ≥75 Years: A Randomized Clinical Trial.

IMPORTANCE: The appropriate treatment target for systolic blood pressure (SBP) in older patients with hypertension remains uncertain. OBJECTIVE: To evaluate the effects of intensive (<120 mm Hg) compared with standard (<140 mm Hg) SBP targets in persons aged 75 years or older with hypertension but without diabetes. DESIGN, SETTING, AND PARTICIPANTS: A multicenter, randomized clinical trial of patients aged 75 years or older who participated in the Systolic Blood Pressure Intervention Trial (SPRINT). Recruitment began on October 20, 2010, and follow-up ended on August 20, 2015. INTERVENTIONS: Participants were randomized to an SBP target of less than 120 mm Hg (intensive treatment group, n = 1317) or an SBP target of less than 140 mm Hg (standard treatment group, n = 1319). MAIN OUTCOMES AND MEASURES: The primary cardiovascular disease outcome was a composite of nonfatal myocardial infarction, acute coronary syndrome not resulting in a myocardial infarction, nonfatal stroke, nonfatal acute decompensated heart failure, and death from cardiovascular causes. All-cause mortality was a secondary outcome. RESULTS: Among 2636 participants (mean age, 79.9 years; 37.9% women), 2510 (95.2%) provided complete follow-up data. At a median follow-up of 3.14 years, there was a significantly lower rate of the primary composite outcome (102 events in the intensive treatment group vs 148 events in the standard treatment group; hazard ratio [HR], 0.66 [95% CI, 0.51-0.85]) and all-cause mortality (73 deaths vs 107 deaths, respectively; HR, 0.67 [95% CI, 0.49-0.91]). The overall rate of serious adverse events was not different between treatment groups (48.4% in the intensive treatment group vs 48.3% in the standard treatment group; HR, 0.99 [95% CI, 0.89-1.11]). Absolute rates of hypotension were 2.4% in the intensive treatment group vs 1.4% in the standard treatment group (HR, 1.71 [95% CI, 0.97-3.09]), 3.0% vs 2.4%, respectively, for syncope (HR, 1.23 [95% CI, 0.76-2.00]), 4.0% vs 2.7% for electrolyte abnormalities (HR, 1.51 [95% CI, 0.99-2.33]), 5.5% vs 4.0% for acute kidney injury (HR, 1.41 [95% CI, 0.98-2.04]), and 4.9% vs 5.5% for injurious falls (HR, 0.91 [95% CI, 0.65-1.29]). CONCLUSIONS AND RELEVANCE: Among ambulatory adults aged 75 years or older, treating to an SBP target of less than 120 mm Hg compared with an SBP target of less than 140 mm Hg resulted in significantly lower rates of fatal and nonfatal major cardiovascular events and death from any cause. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01206062.

Statins and Cataracts--a visual insight.

Cataract is the leading cause of visual impairment, other than uncorrected refractive errors, and the number one cause of preventable blindness worldwide. Common adverse events of statins include statin-related muscle toxicity, elevation of transaminases, diabetes, and possible association with cancer. Publications on the relationship of cataract to statins have reported inconsistent findings. A meta-analysis indicated a 19 % decrease in cataract among statin users. The pleiotropic effects of statins including effects on inflammation and oxidation may mediate a decrease in the rate of cataract formation. On the other hand, bidirectional effects of statins on oxidation and inhibition of appropriate lens epithelial cell development may promote cataractogenesis. Younger age and longer duration of statin therapy was associated with greater benefit while a benefit was not observed among older persons. A definitive way to settle the issue of the relationship of statins to cataract is to perform a randomized clinical trial or include cataract as an end point in epidemiologic studies. An increased risk of cataract may be balanced by the marked benefits of statins for those at high risk for cardiovascular events, while a decreased risk may help increase adherence to statin therapy.

Gender disparity in the use of drug-eluting stents during percutaneous coronary intervention for acute myocardial infarction.

OBJECTIVE: We examined gender disparity in the use of drug-eluting stents (DES) versus bare metal stents (BMS) during percutaneous coronary intervention (PCI) for acute myocardial infarction (AMI), and gender disparity in all-cause mortality after coronary stent implantation for AMI. BACKGROUND: Gender disparities in AMI managements have been well documented, but it is unclear whether these disparities are seen in the type of coronary stent implantation for AMI and outcomes. METHODS: Hospital discharge data from January 1, 2003 through December 31, 2010 in New Jersey from the Myocardial Infarction Data Acquisition System were used to identify 40,215 patients (12,878 women and 27,337 men) with coronary stent implantation for AMI. The in-hospital, short term (30 days) and long term (1 and 5 year) all-cause mortality rates, unadjusted and adjusted for demographics and comorbidities, were determined. RESULTS: Women were older than men and had a higher prevalence of co-morbidities. Men had higher prevalence of prior coronary revascularizations. After adjustment for co-morbidities, there was no significant gender difference in the use of DES versus BMS for AMI, except in 2003 and 2006 where women were found to be more likely to receive a DES versus a BMS. After adjustment, women had higher odds of in-hospital deaths but no difference in short and long-term all-cause mortality rates. CONCLUSIONS: There was no significant gender difference in the proportion of DES implantation versus BMS for AMI in contemporary years. Women treated with either BMS or DES for AMI had higher in-hospital death than men.

Not just chlorthalidone: evidence-based, single tablet, diuretic alternatives to hydrochlorothiazide for hypertension.

Accounting for 15 % of deaths worldwide, hypertension is often treated with hydrochlorothiazide (HCTZ) (50 million prescriptions annually). HCTZ has a <24-h duration of action, is less potent than chlorthalidone and all major antihypertensive drug classes, and is inferior to four antihypertensive drugs for cardiovascular event (CVE) reduction. If there were alternative diuretics, why prescribe HCTZ? Chlorthalidone is often offered as an alternative to HCTZ, but has limited pharmaceutical formulations. However, there are seven evidence-based, single-tablet, alternative diuretics. For reducing CVE, the following are superior to their comparators: chlorthalidone versus four antihypertensives in multiple hypertensive populations; indapamide versus placebo in elderly Chinese (and versus enalapril for left ventricular hypertrophy), triamterene-HCTZ versus placebo in elderly Europeans, amiloride-HCTZ versus three antihypertensives, and indapamide-perindopril versus placebo in three populations. Additionally, chlorthalidone-azilsartan and spironolactone-HCTZ are potent combinations The aldosterone antagonist component of the latter combination has been shown to reduce total mortality by 30 % in heart failure. Five of these seven have multiple dose formulations. Six cost $4-$77 monthly. In conclusion, based on both scientific and practical grounds, new prescriptions for HCTZ are rarely justified.

Lipid lowering in patients with treatment-resistant hypertension: an analysis from the Treating to New Targets (TNT) trial.

AIM: Patients with resistant hypertension are at high risk for adverse cardiovascular events. Efforts have been focused on lowering the surrogate endpoint of blood pressure (BP) with scant focus on reduction of hard cardiovascular endpoints. However, whether or not intensive lipid lowering is beneficial for reducing the risk of cardiovascular events in this high-risk cohort is not known. METHODS AND RESULTS: We evaluated 10 001 patients with coronary artery disease and a low-density lipoprotein cholesterol level <130 mg/dL, randomized to atorvastatin 80 vs. 10 mg, enrolled in the Treating to New Targets trial. Treatment-resistant hypertension (TRH) was defined as BP ≥140 mmHg despite being on three antihypertensive agents or <140 mmHg on four or more agents. Subjects were followed up for a median duration of 4.9 years. The primary outcome was major cardiovascular events (composite of non-fatal myocardial infarction (MI), fatal coronary heart disease (CHD), resuscitated cardiac arrest, and stroke). Among the 10 001 patients in the trial, 1112 (11.1%) patients had TRH. Atorvastatin 80 mg, in patients with TRH, was associated with a significant reduction in the risk of the primary outcome (HR = 0.70; 95% CI 0.52-0.93; P = 0.01), driven largely by a significant reduction in CHD deaths (HR = 0.55; 95% CI 0.32-0.97; P = 0.04). In addition, atorvastatin 80 mg was associated with a reduction in major coronary events (HR = 0.67; 95% CI 0.49-0.93; P = 0.02), and any cardiovascular or coronary event and with a trend (P = 0.05) towards reduction in all-cause mortality (HR = 0.68; 95% CI 0.46-1.01) when compared with atorvastatin 10 mg. The results were similar when analysed for the two separate components of the TRH cohort. CONCLUSION: In subjects with TRH, intensive lipid lowering with atorvastatin 80 mg is associated with a significant reduction in cardiovascular events.

Proceedings from Duke resistant hypertension think tank.

To identify patients at increased risk for cardiovascular outcomes, apparent treatment resistant hypertension (aTRH) is defined as having a blood pressure (BP) above goal despite the use of ≥3 antihypertensive therapies of different classes at maximally tolerated doses, ideally including a diuretic. In light of growing scientific interest in the treatment of this group, a multistakeholder think tank was convened to discuss the current state of knowledge, improve the care of these patients, and identify appropriate study populations for future observational and randomized trials in the field. Although recent epidemiologic studies in selected populations estimate that the prevalence of aTRH is 10% to 15% of hypertensive patients, further large-scale observational studies will be needed to better elucidate risk factors. To spur the development of therapies for aTRH, the development of an "aTRH" label for pharmacologic and device therapies with a developmental pathway including treatment added to the use of existing therapies is favored. Although demonstration of adequate BP lowering should be sufficient to gain Food and Drug Administration approval for therapies targeting aTRH, assessment of improvement in quality of life and cardiovascular outcomes is also desirable and considered in Centers for Medicare and Medicaid Services coverage decisions. Device trials under the aTRH label will need uniform and consistent processes for defining appropriate patient populations as well as postapproval registries assessing both long-term safety and duration of responses. Finally, patients with aTRH are likely to benefit from evaluation by a hypertension team to assure proper patient identification, diagnostic work-up, and therapeutic management before consideration of advanced or novel therapies to lower BP.

The effect of statins on erectile dysfunction: a meta-analysis of randomized trials.

INTRODUCTION: Erectile dysfunction (ED) is common in older men, especially those with comorbidities such as diabetes and atherosclerotic disease, conditions where statins are frequently prescribed. AIM: To examine the effect of statin therapy on ED using the five-item version of the International Inventory of Erectile Function (IIEF). METHODS: We performed a random-effects meta-analysis of studies identified by a systematic search of MEDLINE, Web of Knowledge, the Cochrane Database, and ClinicalTrials.gov. Examination of the 186 retrieved citations resulted in the selection of 11 randomized trials for inclusion in the meta-analysis. MAIN OUTCOME MEASURES: Change in the IIEF score. RESULTS: IIEF increased by 3.4 points (95% CI 1.7-5.0, P = 0.0001) with statins compared to control. This effect remained statistically significant after multiple sensitivity analyses, including analysis for publication bias, a cumulative meta-analysis, and 11 repeated analyses with each study omitted sequentially. The increase in IIEF with statins was approximately one-third to one-half of that previously reported with phosphodiesterase-5 inhibitors and larger than the effect of lifestyle modification. Metaregression showed an increase in benefit with decreasing lipophilicity. The average age of participants and the degree of LDL cholesterol lowering did not alter the effect on IIEF. CONCLUSION: Statins cause a clinically relevant improvement of erectile function as measured by the five-item version of the IIEF.

Cardiopulmonary bypass has a modest association with cancer progression: a retrospective cohort study.

BACKGROUND: Given their frequency of occurrence in the United States, cancer and heart disease often coexist. For patients requiring open-heart surgery, this raises concern that the use of cardiopulmonary bypass (CPB) may cause a transient immunosuppression with the potential to promote the spread and growth of coexisting cancer cells. This study examined the association of cardiopulmonary bypass with cancer progression in a large population-based setting using linked data from several state-wide registries. METHODS: A retrospective cohort study of cancer risk, stage, and mortality in 43,347 patients who underwent coronary artery bypass graft (CABG) surgery with and without CPB in New Jersey between 1998-2004 was conducted. A competing risk analogue of the Cox proportional hazards model with propensity score adjustment and regression on the cause-specific hazard was used to compute relative risk ratios (95% confidence intervals [CIs]) for patients undergoing CABG surgery with and without CPB. RESULTS: An increased risk for overall cancer incidence (17%) and cancer-specific mortality (16% overall, 12% case fatality) was observed; yet these results did not reach statistical significance. Of 11 tumor-specific analyses, an increased risk of skin melanoma (1.66 [95% CI, 1.08-2.55: p=0.02]) and lung cancer (1.36 [95% CI, 1.02-1.81: p=0.03]) was observed for patients with pump versus off-pump open-heart surgery. No association was found with cancer stage. CONCLUSIONS: These results suggest that there may be a relationship between CPB and cancer progression. However, if real, the effect is likely modest at most. Further research may still be warranted with particular focus on skin melanoma and lung cancer which had the strongest association with CPB.