Non-cardiac factors for prediction of response to cardiac resynchronization therapy: The value of baseline, and of serial changes, in red cell distribution width.

BACKGROUND: Increased red blood cell distribution width (RDW) has been associated with poor outcome after cardiac resynchronization therapy (CRT). However, whether baseline RDW, and its serial changes after CRT implant, have incremental prognostic value is unknown. METHODS AND RESULTS: In 148 consecutive patients (age, 68±9years; 122 men) undergoing CRT, RDW was assessed before and 3months after implant. Patients were categorized according to baseline RDW (≤14.5% vs >14.5%); and as "stable", "decreased", "increased", relative to post-implant changes. Primary end-point was a composite of death/HF hospitalization during follow-up (median 21months). A reduction in left ventricular (LV) end-systolic volume by ≥15% at 6-month identified LV reverse remodeling. By multivariable logistic regression analysis "increased" (OR:0.22, 95%CI: 0.07-0.69, P=0.010) and "stable-high" RDW at follow-up (OR: 0.39, 95%CI: 0.17-0.89, P=0.027) showed a lower likelihood to develop LV reverse remodeling, while baseline RDW was no longer predictive of LV remodeling. During follow-up, there were 57 events. Baseline RDW>14.5% (HR: 2.24, 95%CI: 1.05-4.77, P=0.036), "increased" (HR: 2.55, 95% CI: 1.09-5.97, P=0.030) and "stable-high" RDW (HR: 2.95, 95% CI: 1.45-5.99, P=0.003) independently predicted outcome after adjusting for functional improvement after CRT, radial dyssynchrony, BNP, creatinine clearance, and left atrial volume index. However, integrated discrimination improvement and net reclassification improvement were not statistically significant when both baseline RDW and its changes were added to a base predictive model. CONCLUSION: Increased and stable-high values of RDW were independently associated with both LV reverse remodeling and outcome after CRT; however, RDW did not show any incremental predictive value.

Protocol for validating cardiovascular and cerebrovascular ICD-9-CM codes in healthcare administrative databases: the Umbria Data Value Project.

INTRODUCTION: Administrative healthcare databases can provide a comprehensive assessment of the burden of diseases in terms of major outcomes, such as mortality, hospital readmissions and use of healthcare resources, thus providing answers to a wide spectrum of research questions. However, a crucial issue is the reliability of information gathered. Aim of this protocol is to validate International Classification of Diseases, 9th Revision-Clinical Modification (ICD-9-CM) codes for major cardiovascular diseases, including acute myocardial infarction (AMI), heart failure (HF), atrial fibrillation (AF) and stroke. METHODS AND ANALYSIS: Data from the centralised administrative database of the entire Umbria Region (910 000 residents, located in Central Italy) will be considered. Patients with a first hospital discharge for AMI, HF, AF or stroke, between 2012 and 2014, will be identified in the administrative database using the following groups of ICD-9-CM codes located in primary position: (1) 410.x for AMI; (2) 427.31 for AF; (3) 428 for HF; (4) 433.x1, 434 (excluding 434.x0), 436 for ischaemic stroke, 430 and 431 for haemorrhagic stroke (subarachnoid haemorrhage and intracerebral haemorrhage). A random sample of cases, and of non-cases, will be selected, and the corresponding medical charts retrieved and reviewed for validation by pairs of trained, independent reviewers. For each condition considered, case adjudication of disease will be based on symptoms, laboratory and diagnostic tests, as available in medical charts. Divergences will be resolved by consensus. Sensitivity and specificity with 95% CIs will be calculated. ETHICS AND DISSEMINATION: Research protocol has been granted approval by the Regional Ethics Committee. Study results will be disseminated widely through peer-reviewed publications and presentations at national and international conferences.

Statins in acute coronary syndrome: very early initiation and benefits.

The use of 3-hydroxy-3-methylglutaryl coenzyme A reductase (statins) is associated with a marked reduction in morbidity and mortality in patients at high cardiovascular risk or with established cardiovascular disease. In the last decade, several randomized controlled studies have demonstrated the benefit of statins in patients with acute coronary syndrome (ACS). These studies showed that use of statins in patients with ACS is associated with a significant reduction of the risk of recurrent cardiovascular events. Current American College of Cardiology/American Heart Association (ACC/AHA) guidelines recommend (Level of Evidence 1A) the use of statin therapy before hospital discharge for all patients with ACS regardless of the baseline low-density lipoprotein. Although there is no consensus on the preferable time of administration of statins during ACS, some clinical trials and pooled analyses provided substantial support for the institution of an early initiation to improve strategies that target the pathophysiologic mechanism operating during myocardial infarction. In particular, recent findings suggested that the earlier the treatment is started after the diagnosis of ACS the greater the expected benefit. Experimental studies with statins in ACS have shown several other effects that could extend the clinical benefit beyond the lipid profile modification itself. In particular, statins demonstrated the ability to induce anti-inflammatory effects, modulate endothelium and inhibit the thrombotic signaling cascade. Given these recognized potential benefit, statins should conceivably modulate the pathophysiological processes involved in the very early phase of plaque rupture and coronary thrombosis.