Conference coverage of The American College of Chest Physician CHEST 2012 meeting.
Late-Breaking Research Focuses on Pulmonary Vascular Diseases
Although there were a wide variety of disease states covered at this year’s CHEST conference, much of the focus has been on those under the umbrella of pulmonary vascular disease, such as pulmonary arterial hypertension and deep vein thrombosis. Here are some of the new study highlights related to pulmonary vascular disease.
One of the most popular sessions featured study data from the late-breaking study by Rubin et al, “Effect of Macitentan on Morbidity and Mortality in Pulmonary Arterial Hypertension (PAH): Results From the SERAPHIN Trial.” Many recent oral PAH therapies that have used exercise capacity as the primary end point have been approved. In this trial, researchers studied the effect of macitentan, a novel dual endothelin receptor antagonist (ERA) with enhanced tissue penetration, on morbidity and mortality in PAH patients. The research team randomized 742 patients placebo (n = 250), macitentan 3 mg (n = 250), or macitentan 10 mg (n = 242), with mean treatment duration being 85.3, 99.5, and 103.9 weeks, respectively. The study authors report that “Macitentan reduced the risk of occurrence of morbidity and mortality events versus placebo by 30% in the 3-mg group (97.5% confi dence interval [CI]: 4%-48%; P = .0108) and 45% in the 10-mg group (97.5% CI: 24%-61%; P <.0001),” leading them to conclude that “Macitentan demonstrated a signifi cant effect on the combined end point of morbidity and mortality, with a favorable safety profi le, in the largest and longest randomized controlled trial of therapy in PAH to date.”
Sidharta et al released the information from their study, “Single-Dose Pharmacokinetics, Safety, and Tolerability of Macitentan, a New Endothelin Receptor Antagonist, in Subjects with Mild, Moderate, or Severe Hepatic Impairment,” which investigated “the pharmacokinetics (PK), safety, and tolerability of the endothelin receptor antagonist macitentan in subjects with hepatic impairment of varying severity versus healthy subjects.” This open-label, single-center study divided subjects into 4 groups based on hepatic function: mild hepatic impairment; moderate hepatic impairment; severe hepatic impairment; and healthy subjects. All subjects received a single dose of macitentan 10 mg. Length of follow-up varied among the groups, and researchers state that “No effect of hepatic impairment on macitentan PK was concluded when 90% CI of geometric mean PK parameter ratios were within reference limits of 0.8 to 1.25.” Upon fi nishing the study, the research team concluded that “The difference in macitentan PK between healthy and hepatically impaired subjects is not considered clinically relevant,” and added that “Macitentan was well tolerated with no new or unexpected safety fi ndings reported.”
Mehta et al presented data from their study, “Current Clinical Practices in PAH: Challenges and Opportunities to Improve Care.” Because pulmonary arterial hypertension (PAH) is an under-recognized and inadequately treated form of pulmonary vascular disease, the researchers in this study set out to assess current clinical practices of pulmonologists, cardiologists, and primary care physicians (PCPs) in PAH management to “identify knowledge, competency, and practice gaps and barriers to improving patient care.” After developing an educational needs assessment survey consisting of 25 questions, the study authors received 377 physician responses. Among other fi ndings, the researchers reported that “More than 65% of pulmonologists, 75% of cardiologists, and 85% of PCPs reported that their practices do not have an algorithm for PAH management,” and that “Nearly 20% of pulmonologists, 30% of cardiologists, and 40% of PCPs did not recommend right heart catheterization to confirm a diagnosis of PAH.” Upon completion of this study, the researchers concluded that their assessment identified gaps in PAH diagnosis and management, and added that “Further assessment of physicians after participating in educational interventions is planned to demonstrate improvement in clinical practice.”
Ongoing Efforts to Reduce Readmission Rates
The following are highlights of abstracts from CHEST that focus on readmission rates, an increasingly important subject for hospitals that are subject to evolving rules and regulations as they relate to reimbursement.
Ashraf et al presented data from their study, “The Utilization of Trained Volunteers to Decrease Hospital Readmission in Patients With Heart Failure.” The authors note that patients with congestive heart failure (CHF) have a high 30-day hospital readmission rate, often due to both dietary and pharmacological non-compliance. The goal of this study was to determine if trained volunteers could be used to increase patients’ compliance with the treatment of CHF, subsequently reducing their 30-day readmission rate. The research team randomly assigned 137 patients who were hospitalized with acute exacerbation of CHF to either an interventional arm or control arm. The interventional arm patients received “dietary and pharmacologic education by a trained volunteer, and a phone call within 48 hours of discharge.” The 30-day readmission rate in the interventional arm was 7% compared with 19% in the control arm with a relative risk reduction of 63% and an absolute risk reduction of 12%, leading the authors to conclude that “The use of trained volunteer staff to educate patients hospitalized with congestive heart failure about their disease and to reinforce both pharmacologic and non-pharmacologic compliance can improve both 30-day re-hospitalization and morbidity.”
Kasaju et al released the fi ndings from their study, “Can the SOAR Scoring System Predict Mortality and Hospital Readmission in Moderate and High Risk Community-Acquired Pneumonia? A Prospective Validation Study.” The objective of the study was “to determine the validity and accuracy of the systolic blood pressure, oxygenation, age, and respiratory rate (SOAR) scoring system in predicting 30-day all cause mortality and hospital readmission in moderate- to high-risk community-acquired pneumonia (CAP).” After evaluating 119 admitted adult patients with moderate to severe CAP using the SOAR index, the researchers concluded that “SOAR is a simple and rapid tool of prognosticating moderate- to high-risk community acquired pneumonia.”
Wirtz and Allen presented data from their study, “Reduced 30-Day Readmission Rate With Implementation of a COPD Transitional Care Clinic at an Urban Community Hospital.” The purpose of the study was to evaluate to what degree participation in a chronic obstructive pulmonary disease (COPD) transitional care clinic (CTCC) impacts 30-day readmission rates. The research team evaluated the number of Ohio State University Hospital East patients that were discharged with a primary discharge diagnosis of COPD exacerbation. These patients were eligible to be scheduled an appointment in the CTCC within 1 week of discharge, and CTCC visits were conducted by an advanced practice nurse. The researchers concluded that “Further analysis is necessary to determine if the transitional clinic initiative decreased the hospital-wide readmission rate for patients with COPD exacerbation,” and added that “Due to the high no-show rate, future endeavors will be directed at providing transitional care via teleconferencing and in-home visits.”
Cost a Major Concern
Cost was front of mind for many researchers that released new study data at this year’s CHEST conference. Here are some of the highlights from the new research.
Gardner-Gray et al presented the results of their study, “Cost Savings Associated With Compliance to an Early Sepsis Intervention Strategy.” The purpose of this project was to identify early sepsis intervention strategy (ESIS) compliance in an effort to show a reduction of in-hospital costs. The study included a retrospective data analysis of 926 patients with severe sepsis and septic shock in an urban academic tertiary care hospital over a 2-year period. The research team concluded that “Adherence to an ESIS not only reduced mortality but also associated healthcare costs.” Additionally, the authors mentioned that if their results with ESIS compliance are generalized and applied to Medicare and Medicaid patients with severe sepsis, “Cost savings of up to $28 billion per year are projected for the United States.”
Tanriverdi et al examined the cost of acute exacerbation of COPD in a 1-year period in a second-level hospital for their study, “Direct Costs of Acute Exacerbation of COPD Patients in a Second Level Hospital.” The researchers reported that COPD “is a frequent cause of hospitalizations, disability, and death, and generates a great social and economic burden” and that “Most of direct cost of COPD is due to hospitalization, antibiotic use, and bed cost.” In addition, the study authors make a point to mention the importance of preventing COPD by avoiding risk factors such as smoking.
Darnell et al presented data from their study, “Factors Associated With Healthcare Cost in Patients With Chronic Obstructive Pulmonary Disease at the Cincinnati Veterans Administration Medical Center.” The aim of their study was to determine the clinical factors associated with the cost of COPD management by analyzing the relationship between clinical characteristics and healthcare costs due to COPD in patients at the Cincinnati VAMC. After evaluating 3263 unique individuals, the researchers found that “The total number of admissions, clinic visits, physiologic impairment, BMI [body mass index], number of medications, and type of provider are strongly associated with the total cost of COPD management.”
Chan et al released their study, “Catheter-Directed Thrombolysis for Acute Deep Vein Thrombosis: A Costeffectiveness Analysis,” at this year’s conference. The authors noted that “Post-thrombotic syndrome (PTS) often complicates acute deep vein thrombosis (DVT) and may lead to major symptoms that limit quality of life.” Although catheter-directed thrombolysis (CDT) has recently been shown to reduce the risk for PTS, it is “invasive, costly, and may result in major bleeding.” For these reasons, the research team performed a decision analysis in order to determine whether CDT is cost-effective. Ultimately, the study authors determined that “Although CDT may significantly reduce the risk for PTS following acute DVT, this approachis not cost-effective,” and that “The limited impact of CDT and uncertainty surrounding its effi cacy elucidate why this approach proves cost-ineffective.”