Real-World Analysis of Clinical and Demographic Characteristics, Treatment Patterns, and Outcomes in Predominantly Older Patients with HR+/HER2- Metastatic Breast Cancer Receiving Abemaciclib in Routine Clinical Practice.

INTRODUCTION: Hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) is the most frequently diagnosed metastatic breast cancer (mBC) subtype. Combinations of endocrine therapy (ET) with cyclin-dependent kinase 4/6 inhibitors (CDK4 & 6is) improve outcomes compared with ET alone. The efficacy and safety of abemaciclib among patients with HR+/HER2- mBC has been demonstrated in the MONARCH clinical trials; however, there is a paucity of real-world evidence, particularly in older patients. METHODS AND MATERIALS: This retrospective cohort study analyzed the electronic medical record data/charts of adult patients with HR+/HER2- mBC receiving abemaciclib in US-based community oncology settings (1 September 2017 to 30 September 2019). Patients with other primary malignancies, clinical trial enrollment, and incomplete charts were excluded. Patient characteristics, treatment attributes and patterns, and real-world outcomes (clinical benefit rate [CBR] and stable disease among patients with response data available, time to chemotherapy [TTC], time to treatment discontinuation [TTD], and progression-free survival [PFS]) were summarized. Multivariable models evaluated the association between demographic/clinical characteristics and outcomes. RESULTS: Of the 448 final patients, 99% were female, with a median age of 67 years (25% were ≥ 75 years) and median follow-up of 11 months; most (60%) initiated abemaciclib within 2 years of mBC diagnosis. Patients received a median of 1 (P25 = 0, P75 = 3) prior line of therapy for mBC before abemaciclib, including other CDK4 & 6is (48%) and prior chemotherapy (31%); most (57%) had visceral disease. The CBR for the overall population was 53%, with 48% achieving stable disease. The median TTC was not reached; median TTD was 249 days (95% confidence interval [CI]: 202, 304). The median PFS was 329 days (95% CI 266, 386). The discontinuation rate of abemaciclib owing to adverse events (30%) trended higher with age (years) (P = 0.027): 18-49 (n = 42; 19%), 50-64 (n = 155; 25%), 65-74 (n = 138; 32%), 75-84 (n = 82; 37%), ≥ 85 (n = 31; 49%); only 23% of patients overall had a dose hold or reduction prior to discontinuation. CONCLUSIONS: These patients were older than those in the MONARCH studies with substantial visceral disease, and prior chemotherapy and CDK4 & 6i use. Discontinuation rates were higher than in previous real-world studies (11.9%), highlighting the need for proactive management to optimize outcomes, particularly in older patients with mBC.

Characteristics and Outcomes in Cases of US Male Patients with Metastatic Breast Cancer Receiving Abemaciclib in Routine Clinical Practice.

INTRODUCTION: Breast cancer in males constitutes approximately 1% of all breast cancer cases globally. Despite extensive treatment experience with abemaciclib in women with metastatic breast cancer (MBC), real-world evidence in male MBC is lacking. METHODS: This analysis was a part of a broader, retrospective study that analyzed electronic medical records and charts of 448 men and women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) MBC who initiated an abemaciclib-containing regimen from January 2017 through September 2019. Data were collected from the Florida Cancer Specialists & Research Institute and the Electronic Medical Office Logistics Health Oncology Warehouse Language™ databases and summarized descriptively. Real-world best response was described: complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD). RESULTS: Data for six male patients with MBC who were treated with abemaciclib in combination with an aromatase inhibitor (AI) or fulvestrant are presented. Four patients were aged ≥ 75 years, and four patients had ≥ 3 metastatic sites, including visceral involvement. Abemaciclib was initiated in/after third-line (≥ 3L) in four patients, and patients had history of treatment with AI (n = 4), chemotherapy (n = 3), and/or prior cyclin-dependent kinase 4 and 6 inhibitors (n = 2) in the metastatic setting. Abemaciclib + fulvestrant was the most common abemaciclib-containing regimen (n = 4). Best response was documented in four patients: 1 each with CR, PR, SD, and PD. CONCLUSION: Prevalence of male MBC in this dataset was consistent with expected prevalence in the broader population. Most male patients received an abemaciclib-containing regimen in ≥ 3L, with anti-cancer activity observed despite heavy metastatic burden and prior treatments in a metastatic setting.

Within-trial economic analysis of resource use from COMET-ICE: A phase 3 clinical trial evaluating sotrovimab for the treatment of patients with COVID-19 at high risk of progression.

BACKGROUND: Final results for the primary endpoint of the COVID-19 Monoclonal antibody Efficacy Trial-Intent to Care Early (COMET-ICE) randomized controlled trial (NCT04545060) showed a 79% (P < 0.001) adjusted relative risk reduction in longer-than-24-hour hospitalization or death due to any cause in high-risk patients with COVID-19 receiving sotrovimab compared with placebo at Day 29. Given the substantial costs associated with COVID-19 hospitalizations, there is a need to quantify the economic impact of clinical trial outcomes to inform decisionmaking. OBJECTIVE: To compare longer-than-24-hour hospitalization costs (primary objective) and total health care costs (secondary objective) associated with COVID-19 care in the sotrovimab vs placebo group in the COMET-ICE trial. METHODS: This was a 2-step, retrospective, post hoc, within-trial economic analysis. Step 1 was a health care claims (MarketScan) database analysis to source unit cost data (2020 USD) from a US payer perspective for COVID-19 care-related resource use from April 1 through June 30, 2020, among adults diagnosed with COVID-19 at high risk of progression (similar to those enrolled in the COMET-ICE trial). Cost per day for an inpatient event stratified by the following maximum respiratory support levels was obtained: no respiratory support or oxygen therapy only, noninvasive ventilation, and invasive mechanical ventilation. Cost per event was obtained for outpatient resource use. Step 2 was the within-trial economic analysis, in which unit costs from Step 1 were applied to the resource use (based on maximum respiratory support and length of stay for inpatient events and number of visits for outpatient events) observed during the first 29 days post-randomization in COMET-ICE. RESULTS: A total of 1,057 patients from the intent-to-treat COMET-ICE population were included (sotrovimab, n = 528; placebo, n = 529). Baseline demographic and clinical characteristics were well balanced between groups. During 29 days of follow-up, mean (SD) costs for the primary endpoint, longer-than-24-hour hospitalization, were $2,827 ($15,545) in the placebo group and $485 ($5,049) in the sotrovimab group (difference, -$2,342; P < 0.0001). Total health care costs were $2,850 ($15,546) in the placebo group and $525 ($5,070) in the sotrovimab group (difference, -$2,325; P = 0.0021). CONCLUSIONS: This post hoc within-trial economic analysis of COMET-ICE data shows that early treatment with sotrovimab vs placebo may be associated with lower longer-than-24-hour hospitalization costs and total health care costs for COVID-19 care in high-risk patients with COVID-19. These findings may be important in informing decision-making regarding use of sotrovimab in clinical practice. DISCLOSURES: Dr Lokhandwala and Ms Farrelly are employees of Xcenda LLC; Xcenda received funding from GSK to support the conduct of this study and did not receive funding for manuscript development. Mr Acharya and Dr Coutinho were employees of Xcenda LLC during the conduct of the study. Mr Bell and Dr Svedsater are employees of, and hold stocks/shares in, GSK. This study was funded by GSK (study 216974) and Vir Biotechnology, Inc. The study sponsors were involved in the study design; collection, analysis, and interpretation of data; writing of the report; and the decision to submit the report for publication.

Management of hepatocellular carcinoma from diagnosis in routine clinical practice.

Aim: To assess real-world management of patients diagnosed with hepatocellular carcinoma (HCC) within an integrated delivery network. Materials & methods: A retrospective cohort analysis of adults newly diagnosed with HCC from January 2014 to March 2019. Overall survival and treatment journey were assessed over the entire available follow-up period per patient. Results: Of the 462 patients, 85% had ≥1 treatment. The 24-month overall survival rate (95% CI) from first treatment was 77% (72-82%). Majority of Child-Pugh class A (71%) and B (60%) patients received locoregional therapy first. Half (53.6%) of the patients with liver transplantation first were Child-Pugh class C patients. Sorafenib was the predominant systemic therapy. Conclusion: This integrated delivery network data analysis offers a comprehensive insight into the real-world management of HCC.

Retrospective Analysis of Disease Severity, Health Care Resource Utilization, and Costs Among Patients Initiating Belimumab for the Treatment of Systemic Lupus Erythematosus.

PURPOSE: The goal of this study was to evaluate clinical and economic outcomes associated with the initiation of intravenous (IV) belimumab for the treatment of systemic lupus erythematosus (SLE) in clinical practice in the United States. METHODS: This retrospective study used administrative claims data from the IBM MarketScan Commercial Claims and Encounters Database and the Medicare Supplemental and Coordination of Benefits Database. Data for patients with SLE who initiated (index) IV belimumab were collected for the 12 months before (pre-index) and the 12 months after (post-index) belimumab initiation. Outcomes included SLE disease severity and flares, all-cause health care resource utilization (HCRU) and health care costs, and hospital-based costs and service visits. Post hoc analyses of total hospital-based costs were conducted to further explore drivers of mean post-index costs. FINDINGS: Baseline characteristics (N = 908) are as follows: female, 93.4%; mean (SD) age, 45.6 (11.9) years; mean Charlson Comorbidity Index score, 0.9 (2.0); and moderate or severe disease, 94.9%. Disease activity (SLE flare episodes) was significantly reduced between the pre-index and post-index periods (severe flares, 16.4% vs 10.1% [P < 0.0001]; moderate flares, 92.1% vs 85.6% [P < 0.0001]; and mild flares, 77.4% vs 71.1%; [P = 0.0003]). The proportion of patients receiving oral corticosteroids (OCS) was reduced between the pre-index and post-index periods, especially among patients at higher OCS thresholds (prednisone-equivalent dose: ≥60 mg/d, 7.3% vs 4.2%; >40 mg/d, 14.1% vs 7.9%). From the pre-index to the post-index period, few differences in HCRU were observed, although all-cause physician office visits, outpatient visits, and unique prescriptions filled increased significantly. In the 12-month post-index period, patients had a mean of 12.2 (9.0) encounters (eg, outpatient visit or prescription) associated with IV belimumab. All-cause total, medical, and pharmacy costs increased from the pre-index to the post-index period. Mean all-cause hospital-based costs increased from the pre-index to the post-index period ($7735 [26,603] vs $11,030 [88,086]; P = 0.396). However, the 75th, 90th, and 95th percentile costs decreased from the pre-index to the post-index period ($305, $2107, and $3861, respectively). IMPLICATIONS: After initiation of IV belimumab, disease activity (number of moderate and severe SLE flares) and use of OCS were significantly reduced. However, HCRU and costs, including hospital-based costs, were generally greater in the post-index period. Further studies will increase understanding of SLE, with the specific goals of incorporating disease activity measures and long-term outcomes in studies of HCRU, costs, and patient outcomes.

Within-trial economic analysis of flare data from the BLISS-SC trial of subcutaneous belimumab in systemic lupus erythematosus.

OBJECTIVE: The management of systemic lupus erythematosus (SLE) flares can incur substantial healthcare costs. In the phase III BLISS-SC trial, subcutaneous (SC) belimumab 200 mg plus standard therapy was associated with significant reductions in time to severe flare, and risk of flares, versus placebo plus standard therapy, in adults with active SLE. We evaluated whether the reduction in SLE flares with belimumab SC plus standard therapy translated to lower healthcare costs. METHODS: A retrospective, post hoc economic analysis of BLISS-SC data was conducted. Unit costs per flare from claims data were estimated and applied to flares observed in BLISS-SC to quantify costs associated with treating severe flares (primary objective) or flares of any severity (secondary objective). RESULTS: Of 836 patients (n=556 belimumab, n=280 placebo) analysed (94.4% female, mean (standard deviation, SD) age 38.6 (12.3) years), 13.2% and 62.8% had experienced a severe or mild/moderate flare, respectively. Mean (SD) unit costs per severe, moderate, mild or mild/moderate flare were US$9273 (38 800), US$3048 (9321), US$1671 (6202) and US$2303 (7821), respectively. Adjusted mean costs of treating flares were significantly lower with belimumab SC plus standard therapy than placebo plus standard therapy (severe flare, US$927 lower, p<0.001; flare of any severity, US$1379 lower, p<0.001). CONCLUSIONS: This economic analysis of data from the BLISS-SC trial revealed significant cost reductions were associated with treating SLE flares with belimumab SC plus standard therapy versus placebo plus standard therapy. These findings may help to inform decision making about introducing belimumab to healthcare systems. TRIAL REGISTRATION NUMBER: NCT01484496.

Clinical and economic outcomes associated with the use of fluticasone propionate 250 mcg and salmeterol 50 mcg combination versus tiotropium bromide 18 mcg as initial maintenance treatment for chronic obstructive pulmonary disease in managed care.

AIMS: To examine the clinical and economic outcomes associated with the use of long-acting bronchodilators for initial maintenance treatment of chronic obstructive pulmonary disease (COPD) by analyzing health insurance claims data in the US. METHODS: A retrospective, observational, matched cohort study used health insurance claims data (January 2008 to June 2013) to assess COPD-related outcomes for subjects aged ≥40 years. Subjects were assigned to a study cohort according to the first observed prescription fill for a long-acting bronchodilator (fluticasone propionate 250 mcg/salmeterol 50 mcg [FSC] or tiotropium bromide 18 mcg [TIO]). The analysis period for each subject comprised a 1-year pre-index date and 1-year post-index date. Primary outcome measure was total COPD-related costs per-patient per-year (PPPY) during the follow-up period. Secondary outcome measures included COPD-related exacerbations and the components of COPD-related costs. RESULTS: Overall, 24,040 subjects were identified; the analysis sample consisted of 19,090 subjects (9,545 per cohort) with no significant differences between cohorts. Mean COPD-related total costs PPPY were numerically lower among the FSC cohort; however, the difference was not statistically significant ($2,224 [±4,108] vs $2,352 [±3,721], p = .057). There was no difference between cohorts for COPD-related medical costs (p = .894). COPD-related pharmacy costs were significantly, yet modestly, lower in the FSC cohort compared with the TIO cohort ($1,160 [±1,106] vs 1,275 [±1,110], p < .001). There were no statistically significant differences in the rate or number of exacerbations between the matched cohorts. LIMITATIONS: While propensity scoring achieved balance in baseline characteristics, some residual confounding unobserved in the database may be present. CONCLUSIONS: Few clinical and economic differences between subjects initiating maintenance therapy with FSC or TIO were observed.

Use and cost comparison of clobazam to other antiepileptic drugs for treatment of Lennox-Gastaut syndrome.

Background: Lennox-Gastaut syndrome (LGS) is a severe form of childhood-onset epilepsy associated with serious injuries due to frequent and severe seizures. Of the antiepileptic drugs (AEDs) approved for LGS, clobazam is a more recent market entrant, having been approved in October 2011. Recent AED budget impact and cost-effectiveness analyses for LGS suggest that adding clobazam to a health plan formulary may result in decreased medical costs; however, research on clinical and economic outcomes and treatment patterns with these AED treatments in LGS is limited. Objectives: To compare the baseline characteristics and treatment patterns of new initiators of clobazam and other AEDs among LGS patients and compare healthcare utilization and costs before and after clobazam initiation among LGS patients. Methods: A retrospective study of probable LGS patients was conducted using the MarketScan® Commercial, Medicare Supplemental, and Medicaid databases (10/1/2010-3/31/2014). Results: In the Commercial/Medicare Supplemental population, clobazam users were younger, had fewer comorbidities, and more prior AED use than non-clobazam users. In the 12 months pre-treatment initiation, clobazam users had significantly more seizure-related inpatient stays and outpatient visits and higher total seizure-related (P < 0.001) and all-cause (P < 0.001) costs than non-clobazam users. Among clobazam users, when compared to the 12 months pre-clobazam initiation, seizure-related medical utilization and costs were lower in the 12 months post-clobazam initiation (P = 0.004). Total all-cause (P < 0.001) and seizure-related (P = 0.029) costs increased post-clobazam initiation mainly due to the increase in outpatient pharmacy costs. Similar results were observed in the Medicaid population. Conclusions: Baseline results suggest a prescribing preference for clobazam in severe LGS patients. Clobazam users had a reduction in seizure-related medical utilization and costs after clobazam initiation. The improvement in medical costs mostly offset the higher prescription costs following clobazam initiation.

Costs of Diagnostic Assessment for Lung Cancer: A Medicare Claims Analysis.

PURPOSE: To assess the diagnostic costs leading up to a lung cancer diagnosis in patients with abnormal computed tomography (CT) scans. PATIENTS AND METHODS: A retrospective cohort study using the 5% Medicare claims data (January 1, 2009, to December 31, 2011) was conducted. Patients aged 65 to 74 years with an abnormal chest CT scan were identified. Index was defined as the date of the abnormal chest CT scan. Outcomes assessed over a 12-month follow-up after index included lung cancer diagnosis rate and the use and associated costs of follow-up diagnostic tests up to diagnosis of lung cancer. RESULTS: Of 8979 patients identified with an abnormal chest CT scan (mean age, 69.3 ± 2.9 years), 13.9% were diagnosed with lung cancer over 12 months. Chest x-rays were the most common diagnostic test. Of the 19% who underwent a biopsy, 43.6% were not diagnosed with lung cancer during follow-up. The average total diagnostic assessment cost per patient was higher for those with versus without lung cancer ($7567 vs. $3558). Among patients not diagnosed with lung cancer, the median diagnostic cost per patient for those with versus without biopsy was ∼ 28 times higher. Adverse events significantly increased the average cost per biopsy (approximately 4-fold). CONCLUSION: Total lung cancer diagnostic cost was $38.3M in the defined study sample, of which 43.1% was accounted for by biopsied patients without a lung cancer diagnosis. Additional risk stratification is required to decrease unnecessary biopsy referrals and costs. Further, adverse events significantly increased costs.

Prompt initiation of maintenance treatment following a COPD exacerbation: outcomes in a large insured population.

BACKGROUND: The aim of this study was to extend previous findings and determine the value of prompt initiation of maintenance treatment (MT) following COPD exacerbations requiring hospitalization or an emergency department (ED) visit. PATIENTS AND METHODS: Administrative claims data (collected between January 1, 2009 and June 30, 2012) from an employer-sponsored commercially insured population were retrospectively used to identify patients with a COPD exacerbation resulting in hospitalization or an ED visit. Patients initiating approved MT for COPD within 30 days of discharge/diagnosis (prompt) were compared with those initiating MT within 31-180 days (delayed). COPD-related total, medical, and prescription drug costs during a 1-year follow-up period were evaluated using semilog ordinary least square regressions, controlling for baseline characteristics plus COPD-related costs from the previous year. The odds and number of subsequent COPD-related exacerbations during the follow-up were compared between the prompt and delayed cohorts using logistic regression and zero-inflated negative binomial models, respectively. RESULTS: A total of 6,521 patients with a COPD-related hospitalization or an ED visit were included, of whom 4,555 received prompt MT and 1,966 received delayed MT. Adjusted COPD-related total and medical costs were significantly lower for the prompt MT than the delayed MT cohorts (US$3,931 vs US$4,857 and US$2,327 vs US$3,087, respectively; both P<0.010), as were COPD-related prescription costs (US$1,526 vs US$1,683, P<0.010) during the 1-year follow-up period. Patients receiving delayed MT were 68% more likely to have a subsequent exacerbation requiring hospitalization and 80% more likely to have an exacerbation requiring an ED visit. CONCLUSION: Prompt initiation of MT following a COPD-related hospitalization or an ED visit was associated with a significant reduction in COPD-related costs and odds of exacerbation in the following year compared with delayed initiation.

A retrospective study of persistence, adherence, and health economic outcomes of fixed-dose combination vs. loose-dose combination of oral anti-diabetes drugs.

OBJECTIVE: To compare outcomes between patients with type 2 diabetes mellitus (T2DM) using fixed-dose combination (FDC) and loose-dose combination (LDC) products. METHODS: This retrospective cohort study used MarketScan Commercial and Medicare Supplemental data from January 1, 2009-December 31, 2013. The identified population included patients with T2DM and ≥1 additional oral anti-diabetic prescription (of the same regimen [FDC/LDC] as the index prescription) within 12 months following the fill date. Persistence (no ≥30-day gap) and adherence (medication possession ratio [MPR] ≥0.8) were assessed as primary end-points; secondary end-points included hypoglycemia, healthcare resource utilization, and costs. RESULTS: Of 23,361 patients identified, 12,590 (53.9%) were on FDC therapy and 10,771 (46.1%) were on LDC therapy. FDC patients had a significantly lower rate of non-persistence (67.9% vs. 73.4%, p < 0.0001) and a significantly higher rate of adherence to therapy (57.0% vs. 50.7%, p < 0.0001) when compared to LDC patients. Average time to non-persistence was significantly longer among FDC vs. LDC patients (207.1 vs. 186.3 days, p < 0.0001). After adjusting for baseline characteristics, the odds of non-persistence were 21% lower with FDC vs. LDC therapy (OR = 0.79, 95% CI = 0.74-0.85, p < 0.0001), with a 28% higher odds of adherence (OR = 1.28, 95% CI = 1.20-1.36, p < 0.0001). Differences in most secondary outcomes significantly favored FDC therapy, including total predicted monthly all-cause costs ($1008 vs. $1053; p = 0.006) and T2DM-related costs ($142 vs. $155; p < 0.001). LIMITATIONS: Cohort classification was based on prescription claims data. The lack of clinical data limits assessment of potential influencers of FDC vs. LDC decisions, residual confounding was possible, and diabetes-related medical costs only captured claims with a primary diagnosis for diabetes. The results may not be generalizable to populations such as Medicaid. CONCLUSION: Management of T2DM using FDC therapies provides a compliance benefit relative to LDC therapies that may translate to reductions in healthcare utilization and costs.

Do statins improve outcomes in patients with asthma on inhaled corticosteroid therapy? A retrospective cohort analysis.

OBJECTIVES: Animal studies and clinical trials have examined the potential benefits of statins in asthma management with contradictory results. The objective of this study was to determine if asthma patients on concurrent statins are less likely to have asthma-related hospitalisations. DESIGN: A retrospective cohort study using Mississippi Medicaid data for 2002-2004. PARTICIPANTS: Asthma patients ≥18 years were identified using the ICD9 code 493.xx from 1 July 2002 through 31 December 2003. The index date for an exposed subject was any date within the identification period, 180 days prior to which the subject had at least one inhaled corticosteroid prescription and at least an 80% adherence rate to statins. Asthma patients on inhaled corticosteroids, but not on statins, were selected as the unexposed population. The two groups were matched and followed for 1 year beginning the index date. MAIN OUTCOMES MEASURES: Patient outcomes in terms of hospitalisations and ER visits were compared using conditional logistic regression. RESULTS: After matching, there were 479 exposed subjects and 958 corresponding unexposed subjects. The odds of asthma-related hospitalisation and/or emergency room (ER) visits for asthma patients on concurrent statins were almost half the odds for patients not on statins (OR=0.55; 95% CI (0.37 to 0.84); p=0.0059). Similarly, the odds of asthma-related ER visits were significantly lower for patients on statins (OR=0.48; 95% CI (0.28 to 0.82); p=0.0069). CONCLUSION: The findings suggest beneficial effects of statins in asthma management. Further prospective investigations are required to provide more conclusive evidence.

Hospitalization burden among individuals with autism.

The objective of this study was to assess the inpatient care burden among individuals with autism using the 2007 Health Care Utilization Project Nationwide Inpatient Sample [HCUP-NIS]). There were ~26,000 hospitalizations among individuals with autism in 2007, with an overall rate of 65.6/100,000 admissions. Rates of hospitalizations were the highest among individuals with autism aged 10-20 years, males, having household income >$63,000, and with private insurance, respectively. In terms of hospital characteristics, rates were the highest in hospitals in large urban areas, located in the Northeast region, and with teaching status, respectively. Individuals with autism had significantly higher LOS (6.5 vs. 4.2; p < 0.0001) and total charges ($24,862 vs. $23,225; p < 0.0001) as compared to those without autism.

A prospective comparison of cardiac imaging using intracardiac echocardiography with transesophageal echocardiography in patients with atrial fibrillation: the intracardiac echocardiography guided cardioversion helps interventional procedures study.

BACKGROUND: The Intracardiac Echocardiography Guided Cardioversion Helps Interventional Procedures study evaluated the concordance of intracardiac echocardiography (ICE) with transesophageal echocardiography (TEE) in patients with atrial fibrillation (AF). METHODS AND RESULTS: Patients with AF undergoing right heart catheterization underwent left atrium (LA) and interatrial septal (IAS) imaging by TEE and ICE. A blinded comparison of the 2 modalities was performed at a core laboratory. Ninety-five patients aged 58 ± 12 years completed the study. The LA was profiled in all patients with both techniques, and concordance for image quality was 96%. LA appendage (LAA) imaging was achieved in 85% with ICE and 96% with TEE. There was no difference in the presence of spontaneous echo contrast between ICE and TEE during LA imaging, but there was a trend toward a greater incidence in the LAA with TEE (P = 0.109). Intracardiac thrombus was uncommonly seen (TEE, 6.9%; ICE, 5.2%). The concordance for the presence or absence of thrombus was 97% in the LA and 92% in the LAA, but the latter was detected more frequently with TEE. IAS imaging was achieved in 91% with ICE and in 97% with TEE (P = 0.177). Concordance for patent foramen ovale and atrial septal aneurysms was 100% and 96%, respectively. A negative ICE examination was associated with absence of dense echo contrast or thrombus on TEE in 86%. CONCLUSIONS: This study provides validation for the use of ICE for LA and IAS imaging. ICE imaging was less sensitive compared to TEE for LAA thrombus identification. Clinical Trial Registration- URL: http://www.clinicaltrials.gov. Unique identifier: NCT00281073.

Dual site right atrial pacing can improve the impact of standard dual chamber pacing on atrial and ventricular mechanical function in patients with symptomatic atrial fibrillation: further observations from the dual site atrial pacing for prevention of atrial fibrillation trial.

BACKGROUND: The effects of atrial pacing mode on atrial and ventricular function in patients with atrial fibrillation (AF) and bradycardia have not been evaluated. We evaluated atrial and ventricular function during randomization to support pacing (SP), high right atrial pacing (HRA), and dual site right atrial pacing (DAP). METHODS: Seventy-nine patients (66 +/- 12 yr, 46 male) with standard pacing indications and symptomatic AF were randomized to each of three pacing modes (DAP, HRA, SP) for 6 months in a crossover design. Echocardiographic studies were performed at enrollment and the end of each mode. Paired comparisons of atrial and ventricular function parameters were performed between each pacing mode and baseline. RESULTS: HRA pacing in DDDR mode resulted in increased left ventricular (LV) end systolic volume (78 +/- 42 vs. 60 +/- 31 ml, p = 0.001) and reduced LV ejection fraction (44 +/- 14 vs. 50 +/- 11%, p = 0.007) compared to baseline. These parameters did not change during DAP. DAP resulted in increased peak A wave velocity (75 +/- 19 vs. 63 +/- 23 cm/s, p = 0.003) and atrial filling fraction compared to baseline (0.47 +/- 0.15 vs. 0.38 +/- 0.13, p = 0.005). Atrial and ventricular function were similar between control and SP. CONCLUSION: DAP, but not HRA or SP, improved left atrial (LA) function in patients with AF and bradycardia. HRA pacing in DDDR mode resulted in LA dilatation and deterioration of LV function which was not observed with DAP.