Clinical Outcomes In Asymptomatic Patients Research Articles

Practical cardiovascular risk calculator for asymptomatic patients with type 2 diabetes mellitus: PRECISE-DM risk score.

BackgroundObstructive coronary artery disease (OCAD) is a significant predictor of adverse clinical events in asymptomatic patients with type 2 diabetes mellitus (T2DM).HypothesisWe sought to develop an easy‐to‐use risk scoring system to predict OCAD and long‐term clinical outcome in asymptomatic patients with T2DM (PRECISE‐DM).MethodsA total of 2799 asymptomatic patients with T2DM and no prior coronary disease were consecutively enrolled. OCAD was defined as ≥50% coronary artery stenosis on coronary computed tomography angiography (CCTA). A new risk scoring system was developed in 933 patients undergoing CCTA (derivation cohort) and its performance to predict OCAD and major adverse cardiac and cerebrovascular event (MACCE) was compared with other risk estimates. The scoring system was externally validated in 1899 patients not undergoing CCTA (validation cohort).ResultsThe PRECISE‐DM scoring system was created using seven variables that were associated with increased risk of OCAD, with scores ranging from 0 to 9. The scoring system predicted presence of OCAD with a C‐statistic of 0.680 and risk of MACCE with a C‐statistic of 0.708. The UKPDS risk engine and the Framingham risk score showed unreliable performance in prediction of OCAD (C‐statistics 0.531 and 0.577, respectively). Calcium score was highly predictive for OCAD (C‐statistic 0.825) but showed only modest accuracy in predicting MACCE (C‐statistic 0.675). In the external validation cohort, the PRECISE‐DM score showed acceptable discrimination for prediction of MACCE (C‐statistic 0.707).ConclusionsThe PRECISE‐DM scoring system accurately predicted presence of OCAD and risk of MACCE in asymptomatic patients with T2DM.

Vitamin K versus warfarin interruption alone in patients without bleeding and an international normalized ratio > 10

BackgroundReversal of an international normalized ratio (INR) > 10 with vitamin K is recommended in patients experiencing bleeding; however, information on outcomes with reversal using vitamin K in non‐bleeding patients is lacking. ObjectiveTo compare clinical and safety outcomes between non‐bleeding patients receiving warfarin with an INR > 10 who did and did not receive a prescription for vitamin K. Patients/MethodsThis was a retrospective cohort study conducted in an integrated health‐care delivery system. Adult patients receiving warfarin therapy who experienced an INR > 10 without bleeding between 01/01/2006 and 06/30/2018 were included. Patients were assessed for an outpatient dispensing or in‐office administration of vitamin K on the day of or the day after an INR > 10 and then clinically relevant bleeding, thromboembolism, all‐cause mortality, and time to INR < 4 within the next 30 days. ResultsA total of 809 patients was included with 332 and 477 who were and were not dispensed vitamin K, respectively. Overall, mean patient age was 71.7 years, 60.1% were female and the mean INR was 10.4 at presentation. There were no differences between groups in 30‐day rates of bleeding or thromboembolism (both P > .05). Patients dispensed vitamin K had a higher likelihood of mortality (15.1% versus 10.1%, P = .032, adjusted odds ratio = 1.63, 95% confidence interval 1.03 to 2.57). Overall, time to an INR < 4 was similar between groups. ConclusionVitamin K administration was not associated with improved clinical outcomes in asymptomatic patients with an INR > 10.

Prolactinomas and menopause: any changes in management?

Treatment goals in prolactinomas are to correct hypogonadism, restore fertility and control tumor mass in case of macroadenomas. According to current guidelines, medical treatment of asymptomatic postmenopausal women is not indicated. The purpose of this study was to review the current literature pertaining to biological behavior of prolactinomas during menopause, likelihood of successful dopamine agonist withdrawal during this period and possible prolactin-mediated increased morbidity that could modify current management. A comprehensive literature search including papers published until July 2019 was conducted using PubMed and Medline databases. Women with prolactinomas entering menopause have a higher chance of prolactin normalization of treatment compared with women in their reproductive years. Although most prolactin secreting adenomas diagnosed during menopause are large, they respond well to dopamine agonist treatment. Data directly linking hyperprolactinemia with an increased risk of cancer and cardiovascular and metabolic morbidity are inconsistent. There is no data indicating that correction of hyperprolactinemia improves clinical outcomes in asymptomatic patients bearing microadenomas. There is no evidence that justifies changing current recommendations to withhold medical treatment of microprolactinomas in asymptomatic post-menopausal women. Macroprolactinoma patients should be treated according to standard clinical practice.

New Imaging Markers of Clinical Outcome in Asymptomatic Patients with Severe Aortic Regurgitation.

Background: Determining the value of new imaging markers to predict aortic valve (AV) surgery in asymptomatic patients with severe aortic regurgitation (AR) in a prospective, observational, multicenter study. Methods: Consecutive patients with chronic severe AR were enrolled between 2015–2018. Baseline examination included echocardiography (ECHO) with 2- and 3-dimensional (2D and 3D) vena contracta area (VCA), and magnetic resonance imaging (MRI) with regurgitant volume (RV) and fraction (RF) analyzed in CoreLab. Results: The mean follow-up was 587 days (interquartile range (IQR) 296–901) in a total of 104 patients. Twenty patients underwent AV surgery. Baseline clinical and laboratory data did not differ between surgically and medically treated patients. Surgically treated patients had larger left ventricular (LV) dimension, end-diastolic volume (all p < 0.05), and the LV ejection fraction was similar. The surgical group showed higher prevalence of severe AR (70% vs. 40%, p = 0.02). Out of all imaging markers 3D VCA, MRI-derived RV and RF were identified as the strongest independent predictors of AV surgery (all p < 0.001). Conclusions: Parameters related to LV morphology and function showed moderate accuracy to identify patients in need of early AV surgery at the early stage of the disease. 3D ECHO-derived VCA and MRI-derived RV and RF showed high accuracy and excellent sensitivity to identify patients in need of early surgery.

PREDICTORS OF LONG-TERM CLINICAL OUTCOME IN PATIENTS WITH MILD DIASTOLIC DYSFUNCTION ON ECHO

Uncertainty continues regarding factors that predict adverse clinical outcomes in asymptomatic patients with mild (Grade I) diastolic dysfunction (MDD) as impaired relaxation on echo. We identified 535 consecutive asymptomatic MDD patients (by ASE criteria) in 2010 and followed them through August

A prospective two-center study on the associations between microalbuminuria, coronary atherosclerosis and long-term clinical outcome in asymptomatic patients with type 2 diabetes mellitus: evaluation by coronary CT angiography.

This study assessed the associations between microalbuminuria in asymptomatic patients with type 2 diabetes and the presence, extent, and severity of coronary atherosclerosis, as measured by coronary computed tomography angiography (CCTA), and the long-term clinical outcomes. In total, the study enrolled 284 consecutive eligible asymptomatic patients with type 2 diabetes and without known coronary artery disease (CAD), who then underwent CCTA and 24h urine albumin measurements. Microalbuminuria was defined as 30-300mg/day urinary albumin excretion. Obstructive CAD, as measured by CCTA, was defined as maximum intra-luminal stenosis ≥50%. Patients with and without microalbuminuria were compared in terms of obstructive CAD prevalence, and the extent and severity of coronary atherosclerosis. They were evaluated using the following data: coronary artery calcium score (CACS), atheroma burden obstructive score (ABOS), segment involvement score (SIS) and segment stenosis score (SSS). All-cause mortality within a follow-up period of 5years was also compared. Compared to patients without microalbuminuria, patients with microalbuminuria were more likely to have obstructive CAD (p=0.004). Microalbuminuria was associated with higher ABOS (p=0.010), SIS (p=0.029), and SSS (p=0.011), except for CACS (p=0.058). Multivariable analyses adjusted for conventional cardiovascular risk factors revealed that microalbuminuria was an independent predictor of obstructive CAD [odds ratio 2.255, confidence intervals (CI) 1.121-4.538, p=0.023] and all-cause mortality (hazard ratio 3.469, CI 1.319-9.121, p=0.012). In asymptomatic patients with type 2 diabetes, microalbuminuria was associated with increased risk of CAD and poorer clinical outcomes.

Routine cervical length and fetal fibronectin screening in asymptomatic twin pregnancies: is there clinical benefit?

Objective: To determine whether routine cervical length (CL) and fetal fibronectin (fFN) screening is associated with improved clinical outcomes in asymptomatic patients with twin pregnancies.Study design: We compared outcomes between two large cohorts of twin pregnancies who delivered in New York City from 2003 to 2012. One cohort (n = 532) was managed by a single group practice, delivered at one large academic medical center, and underwent routine serial CL and fFN screening. The second cohort (n = 456) delivered at a second large academic center and only underwent CL and fFN testing as clinically indicated. Outcomes measured include cerclage placement, preterm birth (PTB), spontaneous PTB (sPTB), and antenatal corticosteroid (ACS) exposure.Results: Rates of cerclage placement, PTB, and SPTB were similar between the two groups. However, routine CL and fFN screening was associated with improved rates of ACS exposure in patients who delivered <34 weeks (91.3% versus 74.7%, p = 0.005) and 34–36 6/7 weeks (41.3% versus 13.9%, p < 0.001) without increased ACS exposure in women who delivered at term. In patients who delivered <34 weeks, routine CL and fFN screening was significantly associated with improved rates of ACS exposure within 1–14 days of delivery and within 1–7 days of delivery.Conclusion: In twin pregnancies, routine CL and fFN screening does not reduce the risk of PTB or SPTB. However, the routine use of these tests is associated with significantly improved ACS exposure and timing for women who deliver preterm without increasing ACS exposure to women who deliver at term.

Four-year clinical outcome in asymptomatic patients undergoing coronary computed tomography angiography

Background Percutaneous coronary intervention (PCI) is indicated for angina with coronary stenosis. However, PCI for asymptomatic coronary stenosis remains controversial. We prospectively followed a group of patients for four years who underwent coronary computed tomography angiography (CCTA) for major adverse cardiac events (MACE). We hypothesized that the results of this trial would reliably reflect the natural outcome of the coronary disease. Methods Consecutive patients who underwent CCTA from June 2008 to May 2009 were selected. Those who could not be reached by telephone, had significant angina, had CT images that were not interpretable, or poor kidney and left ventricular (LV) function were excluded. The patients were divided into five groups: group A normal CCTA without stenosis, group B mild stenosis (1%-49%), group C moderate stenosis (50%-74%), group D severe stenosis (≥75%) and they were treated with optimal medical therapy (OMT) or PCI. The group E had PCI before the CCTA examination. The patients were then followed for MACE after different treatments. MACE included acute myocardial infarction (MI), heart failure (HF) and death. Results The patient population consisted of 419 patients. The follow-up time was (51±5) months. The age was (60±31) years. Male made up 67.78% of the population (n=284). A total of 51 cases of MACE occurred including 25 MI, eight HF and 18 all-cause deaths. There was no MACE in group A. Although MACE occurred in two patients in group B, they were not attributed to cardiac death. We further compared the MACE in groups C-E and no significant difference was found (P &gt;0.05). However, a difference was detected among patients with unstable angina pectoris (UAP), stable angina pectoris (SAP), re-hospitalization, and cerebrovascular events from groups A-E (P &lt;0.05). The plaque scores were used to predict MACE. The scores progressively increased significantly with lesion severity (P &lt;0.05). Receiver operating curve (ROC) was performed to determine the sensitivity and specificity in predicting MACE. Our scores predicted MI with area of 0.76, predicted HF with area of 0.77, and predicted death with area of 0.70. Conclusions Normal and mild lesions had very few events. With increased stenosis the MACE rate increased progressively. PCI did not significantly reduce the MACE in comparison with OMT in asymptomatic patients. Furthermore, UAP, re-hospitalization, and re-PCI were significantly increased in patients who were treated with PCI.

4-year Clinical Outcome in Asymptomatic Patients Undergoing Coronary Computed Tomography Angiography

4-year Clinical Outcome in Asymptomatic Patients Undergoing Coronary Computed Tomography Angiography

Letter by Meurin et al Regarding Article, “Early Surgery versus Conventional Treatment in Asymptomatic Very Severe Aortic Stenosis”

To the Editor: We respectfully disagree with the methodology and the conclusion of the article published by Kang et al1 in the April 6, 2010 issue of Circulation . Indeed, we believe that this study was not designed to affirm that, “Compared with the conventional treatment strategy, early surgery is therefore a therapeutic option to further improve clinical outcomes in asymptomatic patients with very severe aortic stenosis and low operative risk.” In our …

Risk stratification in asymptomatic moderate to severe aortic stenosis: the importance of the valvular, arterial and ventricular interplay

ObjectiveWe sought to evaluate prognostic markers of clinical outcome in asymptomatic patients with moderate to severe aortic stenosis (AS).DesignProspective follow-up of asymptomatic patients with moderate to severe AS. The patients...

Early Surgery Versus Conventional Treatment in Asymptomatic Very Severe Aortic Stenosis

The optimal timing of surgical intervention remains controversial in asymptomatic patients with very severe aortic stenosis. We therefore compared the long-term results of early surgery and a conventional treatment strategy. From 1996 to 2006, we prospectively included a total of 197 consecutive asymptomatic patients (99 men; age, 63+/-12 years) with very severe aortic stenosis. Patients were excluded if they had angina, syncope, exertional dyspnea, ejection fraction <0.50, significant mitral valve disease, or age >85 years. Very severe aortic stenosis was defined as a critical stenosis in the aortic valve area < or =0.75 cm(2) accompanied by a peak aortic jet velocity > or =4.5 m/s or a mean transaortic pressure gradient > or =50 mm Hg on Doppler echocardiography. The primary end point was defined as the composite of operative mortality and cardiac death during follow-up. Early surgery was performed on 102 patients, and a conventional treatment strategy was used for 95 patients. There were no significant differences between the 2 groups in terms of age, gender, European System for Cardiac Operative Risk Evaluation score, or ejection fraction. During a median follow-up of 1501 days, the operated group had no operative mortalities, no cardiac deaths, and 3 noncardiac deaths; the conventional treatment group had 18 cardiac and 10 noncardiac deaths. The estimated actuarial 6-year cardiac and all-cause mortality rates were 0% and 2+/-1% in the operated group and 24+/-5% and 32+/-6% in the conventional treatment group, respectively (P<0.001), and for 57 propensity score-matched pairs, the risk of all-cause mortality was significantly lower in the operated group than in the conventional treatment group (hazard ratio, 0.135; 95% confidence interval, 0.030 to 0.597; P=0.008). Compared with the conventional treatment strategy, early surgery in patients with very severe aortic stenosis is associated with an improved long-term survival by decreasing cardiac mortality. Early surgery is therefore a therapeutic option to further improve clinical outcomes in asymptomatic patients with very severe aortic stenosis and low operative risk.

Evaluation of Late Rectal Damage After Radiotherapy for Prostate Cancer

Rectal mucosal damage during radiotherapy (RT) for prostate cancer may occur in acute or chronic form. Although symptoms are considered an unreliable guide of RT-induced injury, late toxicity is mainly based on patients' complain. Endoscopy gives the best estimation of rectal toxicity and also permits prolonged evaluation of rectal mucosa. Aim: To endoscopically describe the natural history of telangiectases (the most frequently observed mucosal abnormality) and their correlation with clinical outcome in asymptomatic patients after RT for prostate cancer.

Quantitative Echocardiographic Determinants of Clinical Outcome in Asymptomatic Patients With Aortic Regurgitation: A Prospective Study

The purpose of this study was to define the link between aortic regurgitation (AR) quantitation and clinical outcome in asymptomatic patients with AR.Quantitative American Society of Echocardiography (QASE) thresholds are recommended for AR assessment, but impact on clinical outcome is unknown.We prospectively enrolled (1991 to 2003) 251 asymptomatic patients (age 60 +/- 17 years) with isolated AR and ejection fraction > or =50% with quantified AR and left ventricular (LV) volumes using Doppler-echocardiography.Survival under medical management was independently determined by baseline regurgitant volume (RVol) (adjusted hazard ratio [HR] 1.22 [95% confidence interval (CI) 1.08 to 1.35] per 10 ml/beat, p = 0.002) and effective regurgitant orifice (ERO) (adjusted HR 1.52 [95% CI 1.19 to 1.91] per 10 mm(2), p = 0.002), which superseded traditional AR grading. Patients with QASE-severe AR (RVol > or =60 ml/beat or ERO > or =30 mm(2)) versus QASE-mild AR (RVol <30 ml and ERO <10 mm(2)) had lower survival (10 years: 69 +/- 9% vs. 92 +/- 4%, p = 0.05) independently of all clinical characteristics (adjusted HR 4.1 [95% CI 1.4 to 14.1], p = 0.01) and lower survival free of surgery for AR (10 years: 20 +/- 5% vs. 92 +/- 4%, p < 0.001, adjusted HR 12.9 [95% CI 5.4 to 38.5]). Cardiac events were considerably more frequent with QASE-severe versus -moderate or -mild AR (10 years: 63 +/- 8% vs. 34 +/- 6% and 21 +/- 8%, p < 0.0001). Independent determinants of cardiac events were quantitative AR grading (QASE-severe adjusted HR 5.2 [95% CI 2.2 to 14.8], p < 0.001; QASE-moderate adjusted HR 2.4 [95% CI 1.06 to 6.6], p = 0.035), which superseded traditional AR assessment (p < 0.001) and LV end-systolic volume index (ESVI) (adjusted HR 1.09 [95% CI 1.03 to 1.14 per 10 ml/m(2)], p = 0.002), which superseded LV M-mode diameters. In QASE-severe AR, patients with ESVI > or =45 versus <45 ml/m(2) had higher cardiac event rates (10 years: 87 +/- 8% vs. 40 +/- 10%, p < 0.001). Cardiac surgery for AR reduced cardiac events in patients with QASE-severe AR (adjusted HR 0.23 [95% CI 0.09 to 0.57], p = 0.002).Echocardiographic quantitation of AR severity and ESVI provides independent and superior predictors of clinical outcome in asymptomatic patients with AR and ejection fraction > or =50% and should be widely clinically applied. Patients with QASE-severe AR and ESVI > or =45 ml/m(2) should be carefully considered for cardiac surgery, which reduces cardiac events risk.

The late open artery hypothesis—A decade later

Background Early reperfusion after myocardial infarction has been proved to preserve left ventricular function and reduce mortality. However, a significant number of patients have persistent occlusion of the infarct-related artery late (days to weeks) after myocardial infarction because of ineligibility for thrombolytic therapy, failure of reperfusion, or reocclusion. Methods In this report we review the data on the potential mechanisms and benefits of late reperfusion and present prospective data on the incidence of and current practice patterns for the management of persistently occluded infarct-related arteries late after myocardial infarction. Results Although several studies have associated late patency of the infarct-related artery with improved long-term clinical outcome, they were nonrandomized and reflect selection bias. Furthermore, data on late patency from the largest study, Global Utilization of Steptokinase and Tissue Plasminogen Activator for Occluded Arteries (GUSTO-I), failed to confirm independent benefits of an open infarct-related artery 1 year after myocardial infarction. The randomized data on the effects of percutaneous transluminal coronary angioplasty for occluded infarct-related arteries late after myocardial infarction are limited and inconclusive. Conclusions The hypothesis that late reperfusion by percutaneous coronary intervention days to weeks after myocardial infarction results in improved long-term clinical outcomes in asymptomatic patients with occluded infarct-related artery is currently being tested in the randomized, multicenter Occluded Artery Trial. (Am Heart J 2001;142:411-21.)