61 results match your criteria: "CTI Clinical Trial and Consulting Services[Affiliation]"

This study aimed to quantify the healthcare burden of clinically significant tricuspid regurgitation (TR) in patients with and without heart failure (HF). Data were from the IBM MarketScan Research Databases from October 2011 to September 2016. Eligible patients met the following inclusion criteria: age ≥18 with a TR diagnosis, 12 months pre (baseline), and 6 months post (landmark) medical enrollment.

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Background: Atypical haemolytic uraemic syndrome (aHUS) is a rare, potentially life-threatening condition caused by dysregulation of the complement pathway. Eculizumab is currently the only approved treatment for this disorder.

Objective: Our objective was to investigate the impact of early administration of eculizumab on inpatient resource use and hospitalisation costs in 222 patients with aHUS.

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Background Or Purpose: The purpose of this analysis was to report on efficacy of a standardized workflow for atrial fibrillation (AF) ablation using technology advances such as 3D imaging and contact force sensing in a real-world setting.

Methods: Consecutive AF ablations from 2014 to 2015 at a high-volume site in Belgium were included. The workflow consisted of a pre-specified procedure sequence including 3D modeling followed by radiofrequency encircling of the pulmonary veins (25 W posterior wall, 35 W anterior wall) with a THERMOCOOL SMARTTOUCH® Catheter guided by CARTO VISITAG™ Module (2.

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The objective of this study was to quantify the financial healthcare burden of mitral regurgitation (MR) on medically managed heart failure (HF) patients. Data from the Truven Health MarketScan Commercial Claims and Medicare Supplemental Databases were analyzed. Included patients had a minimum of 1 inpatient or 2 outpatient claims for HF with a 6-month preperiod (baseline).

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Objectives: The objective of our review was to systematically assess available evidence on the effectiveness, safety and efficiency of a spring sensor-irrigated contact force (CF) catheter (THERMOCOOL SMARTTOUCH Catheter (ST)) for percutaneous ablation of paroxysmal or persistent atrial fibrillation (AF), compared with other ablation catheters, or with the ST with the operator blinded to CF data.

Design: Systematic literature review and meta-analysis.

Background: Emerging evidence suggests improved clinical outcomes of AF ablation using CF-sensing catheters; however, reviews to date have included data from multiple, distinct CF technologies.

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Introduction: Orthotopic liver transplantation has been used as a treatment for hereditary transthyretin-mediated (hATTR) amyloidosis, a rare, progressive, and multisystem disease.

Research Question: The objective is to evaluate survival outcomes post-liver transplantation in patients with hATTR amyloidosis in the United States and assess whether previously published prognostic factors of patient survival in hATTR amyloidosis are generalizable to the US population.

Design: This cohort study examined patients with hATTR amyloidosis undergoing liver transplant in the United States (N = 168) between March 2002 and March 2016 using data reported to the Organ Procurement and Transplantation Network (UNOS)/United Network for Organ Sharing (OPTN).

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Background: Catheter ablation technology has evolved rapidly in recent years. There is a need to understand the impact of these advances on efficiency, safety, and effectiveness in real-world populations. The objective of this study was to evaluate a standardized workflow that integrates a contact force (CF) catheter and stability module in an attempt to optimize efficiency and clinical outcomes of paroxysmal atrial fibrillation (PAF) ablation, and to compare the outcomes of this workflow with existing ablation technologies at a high-volume center.

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Introduction: It was hypothesized that patients experiencing at least one tacrolimus formulation switch may require more frequent therapeutic drug monitoring, subsequent dose adjustments, and a potential for untoward clinical outcomes than patients who remain on a single formulation.

Methods: Eligible patients were adult kidney transplant recipients with stable renal function at month 3 post-transplant and no evidence of acute rejection, receiving an oral, tacrolimus-based regimen. Patients were categorized into two groups (fixed or variable formulation) using the US National Drug Code (NDC) on the basis of tacrolimus formulation usage over the 12-month period.

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Purpose: The procedural endpoint following cryoballoon ablation (CA) for paroxysmal atrial fibrillation (PAF) is pulmonary vein isolation (PVI), which is typically confirmed by entrance/exit block using a circular mapping catheter. The present study added an assessment of ablation gaps with high-density voltage mapping after standard confirmation of PVI. Relationships between the need for touch-up ablation, patient characteristics, and atrial arrhythmia recurrence were explored.

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Background: Fluoroscopy exposure during catheter ablation is a health hazard to patients and operators. This study presents the results of implementing a low-fluoroscopy workflow using modern contact force (CF) technologies in paroxysmal atrial fibrillation (PAF) ablation.

Methods: A fluoroscopy reduction workflow was implemented and subsequent catheter ablations for PAF were evaluated.

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Cost-Effectiveness of Bone SPECT/CT in Painful Total Knee Arthroplasty.

J Nucl Med

November 2018

Department of Orthopaedic Surgery and Traumatology, Kantonsspital Baselland (Bruderholz, Liestal, Laufen), Bruderholz, Switzerland; and.

The purpose of this study was to quantify the economic value of bone SPECT/CT versus CT or metal artifact reduction sequence (MARS)-MRI for the diagnostic assessment of recurrent moderate-to-severe pain after total knee arthroplasty (TKA). An Excel-based simulation model was developed to compare bone SPECT/CT versus CT or MARS-MRI from a payer perspective. Clinical endpoints (diagnosis-delayed or otherwise, and the subsequent treatment and complications) and their corresponding cost data (2017 U.

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Aims: The objective of this study was to quantify the treatment costs and revision surgery rates in chronic rhinosinusitis (CRS) patients, with and without nasal polyposis (CRSwNP and CRSsNP), who require treatment with endoscopic sinus surgery (ESS). The additive contributions of nasal polyposis (NP) and revision surgery to 1-year costs were a primary focus.

Materials And Methods: Adults (aged 18-64 years) undergoing ESS for CRS in 2012-2015 were identified within the Blue Health Intelligence database and used to estimate revision rates.

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Objective: This study aimed to estimate the annual health care burden for patients with adrenal insufficiency [AI; primary (PAI), secondary to pituitary disorder (PIT), and congenital adrenal hyperplasia (CAH)] using real-world data.

Methods: Using a US-based payer database comprising >108 million members, strict inclusion criteria with diagnostic codes and pharmacy records were used to identify 10,383 patients with AI. This included 1014 patients with PAI, 8818 with PIT, and 551 with CAH, followed for >12 months.

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Objective: To determine the net economic impact of switching from low-osmolar contrast media (LOCM) to iso-osmolar contrast media (IOCM; iodixanol) in patients undergoing inpatient coronary or peripheral angioplasty in the United States (US).

Methods: A budget impact model (BIM) was developed from a hospital perspective. Nationally representative procedural and contrast media prevalence rates, along with MARCE (major adverse renal cardiovascular event) incidence and episode-related cost data were derived from Premier Hospital Data (October 2014 to September 2015).

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Aims: Patients with critical limb ischemia (CLI) have an increased risk of major amputation. The initial treatment approach for CLI may significantly impact the subsequent risk of major amputation or death. The objective of this study was to describe the initial treatment approaches of patients with CLI and the limb outcomes associated with each approach.

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Mortality, stroke, and heart failure in atrial fibrillation cohorts after ablation versus propensity-matched cohorts.

Pragmat Obs Res

May 2017

Cardiology & Electrophysiology, Heart Rhythm Centre, NIHR Cardiovascular Research Unit, The Royal Brompton Hospital, and National Heart and Lung Institute, Imperial College, London, UK.

Background: We sought to determine from key clinical outcomes whether catheter ablation of atrial fibrillation (AF) is associated with increased survival.

Methods And Results: Using routinely collected hospital data, ablation patients were matched to two control cohorts using direct and propensity score methodology. Four thousand nine hundred ninety-one ablation patients were matched 1:1 with general AF controls without ablation.

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Article Synopsis
  • Atrial fibrillation (AF) is more common in older adults, but there's limited information on how effective AF ablation (a treatment method) is for this age group in improving their quality of life and reducing healthcare use.
  • A study involving 736 patients (some aged 65 and older) showed that both older and younger patients experienced similar success rates and hospital stays after undergoing the procedure, with significant improvements in quality of life for both groups after one year.
  • The results suggest that catheter ablation can be a beneficial treatment option for older patients with AF, as they experienced fewer hospitalizations and similar enhancements in quality of life compared to their younger counterparts.
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Atrial Fibrillation Diagnosis Timing, Ambulatory ECG Monitoring Utilization, and Risk of Recurrent Stroke.

Circ Cardiovasc Qual Outcomes

January 2017

From the University of Birmingham Institute of Cardiovascular Sciences, City Hospital, Birmingham, UK (G.Y.H.L.); Health Outcomes Research (T.D.H.) and Health Economics & Outcomes Research (M.E.Q.), CTI Clinical Trial and Consulting Services, Inc, Cincinnati, OH; Diagnostics and Monitoring Research, Medtronic, Mounds View, MN (P.D.Z.); and Cardiac Electrophysiology, Stanford University School of Medicine, VA Palo Alto Healthcare System, Palo Alto, CA (M.P.T.).

Background: The risk of recurrence after an initial ischemic stroke or transient ischemic attack (TIA) may be impacted by undiagnosed atrial fibrillation (AF). We therefore assessed the impact of AF diagnosis and timing on stroke/TIA recurrence rates in a large real-world sample of patients.

Methods And Results: Using commercial claims data (Truven Health Analytics MarketScan), we performed a retrospective cohort study of patients with an index stroke or TIA event recorded in years 2008 through 2011.

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Objective: The objective of this study was to estimate resource utilization and expenditures for patients with acute myeloid leukemia (AML) in a real-world claims database.

Research Design And Methods: AML patients were identified in MarketScan claims databases between 1 January 2009 and 31 January 2015. Patients had a minimum of two AML diagnosis codes, hospitalization within 14 days after initial diagnosis, and ≥6 months of enrollment before initial diagnosis.

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Introduction: Hypogonadism is broadly associated with increases in chronic comorbid conditions and health care costs. Little is known about the specific impact of primary and secondary hypogonadism on health care costs.

Aim: To characterize the health care cost and utilization burden of primary and secondary hypogonadism in a population of US men with commercial insurance.

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This systematic review and meta-analysis (MA) investigates the impact of elevated blood phenylalanine (Phe) on neuropsychiatric symptoms in adults with phenylketonuria (PKU). The meta-analysis of PKU is challenging because high-quality evidence is lacking due to the limited number of affected individuals and few placebo-controlled, double-blind studies of adults with high and low blood Phe. Neuropsychiatric symptoms associated with PKU exceed general population estimates for inattention, hyperactivity, depression, and anxiety.

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Atrial fibrillation (AF) affects approximately 350,000 Canadians and has an estimated annual economic burden exceeding $800 million dollars. Anti-arrhythmic drug (AAD) therapy and catheter ablation (CA) are the two common treatments for paroxysmal AF. However, the upfront costs of CA are quite substantial.

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Exploring Inpatient Hospitalizations and Morbidity in Patients With Adrenal Insufficiency.

J Clin Endocrinol Metab

December 2016

Medical School (P.M.S.), University of Leeds, Leeds LS2 9NL, United Kingdom; Neuroendocrine Unit (B.M.K.B.), Massachusetts General Hospital, Boston, Massachusetts; Shire (C.M.), 6300 Zug, Switzerland; CTI Clinical Trial and Consulting Services, Inc (C.G., M.P.R.), Cincinnati, Ohio 45212; and Department of Internal Medicine and Clinical Nutrition (G.J.), Institute of Medicine, Sahlgrenska Academy, University of Göteborg and Department of Endocrinology, Sahlgrenska University Hospital, Göteborg SE-413 45, Sweden.

Context: Patients with adrenal insufficiency (AI) (primary AI [PAI], secondary AI due to a pituitary disorder [PIT] and congenital adrenal hyperplasia [CAH]) have reduced life expectancy; however, the underlying explanation remains unknown.

Objective: To evaluate characteristics, comorbidities, and hospitalizations in AI patients.

Design: Retrospective observational.

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Objective: The recent development of the EDWARDS INTUITY Elite™ (EIE) valve system enables the rapid deployment of a prosthetic surgical heart valve in an aortic valve replacement (AVR) procedure via both the minimally invasive (MISAVR) and conventional (CAVR) approaches. In order to understand its economic value, this study performed a cost evaluation of the EIE valve system used in a MIS rapid-deployment approach (MIS-RDAVR) vs MISAVR and CAVR, respectively, compared to standard prosthetic aortic valves.

Methods: A simulation model was developed using TreeAge (and validated with MS Excel) to compare the inpatient utilization and complication costs for each treatment arm.

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Incidence, Treatment Intensity, and Incremental Annual Expenditures for Patients Experiencing a Cardiac Implantable Electronic Device Infection: Evidence From a Large US Payer Database 1-Year Post Implantation.

Circ Arrhythm Electrophysiol

August 2016

From the Department of Medicine, Mayo Clinic College of Medicine, Rochester, MN (M.R.S.); CRHF HEOR, Reimbursement and Evidence, Medtronic, Plc, Mounds View, MN (E.L.E.); Health Economics and Outcomes Research (M.P.R., C.G.) and Regulatory & Scientific Affairs (L.A.W.), CTI Clinical Trial and Consulting Services, Inc, Cincinnati, OH; and Department of Medicine, Thomas Jefferson University Hospital, Philadelphia, PA (A.J.G.).

Background: Because of the increasing use of cardiac implantable electronic devices (CIEDs), it is important to estimate the incidence and annual healthcare expenditures associated with CIED infections.

Methods And Results: Patients with a record of an initial or replacement (full implant or generator only) CIED implant during the calendar years 2009 to 2012 in MarketScan Commercial Claims and Medicare Supplemental database were identified. CIED infections were classified into 4 categories: (1) infection not managed by inpatient admission nor implant removal, (2) infection managed by inpatient admission but no implant removal, (3) infection managed by an implant removal either in an inpatient or in an outpatient setting, and (4) infection with severe sepsis and managed in an inpatient setting with implant removal.

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