Evaluation Study of Congestive Heart Failure and Pulmonary Artery Catheterization Effectiveness (ESCAPE-BioLINCC)

Accessing Data Please refer to “Authorized Access” below regarding accessing data through the BioData Catalyst ecosystem. The data from this accession is not available for download through dbGaP. Objectives To test whether pulmonary artery catheter use was safe and could improve clinical outcomes in participants hospitalized with recurrent heart failure. Background Pulmonary artery catheters have been used to guide adjustment of therapy in multiple settings, but recent studies have raised concern that pulmonary artery catheters may lead to increased mortality in hospitalized participants. Participants A total of 433 participants at 26 sites were enrolled, and randomly assigned to receive therapy guided by clinical assessment and the pulmonary artery catheter or clinical assessment alone. Patients with acute decompensation in which the attending heart failure physician considered pulmonary artery catheterization (PAC) was required or likely to be required within the next 24 hours were entered into a PAC registry. A total of 439 patients were added to the registry. Conclusions Therapy to reduce volume overload during hospitalization for heart failure led to marked improvement in signs and symptoms of elevated filling pressures, with or without the pulmonary artery catheter. Addition of the pulmonary artery catheter to careful clinical assessment did not impact overall mortality and hospitalization. Future trials should test noninvasive assessments with specific treatment strategies that could be used to better tailor therapy for both survival time and survival quality as valued by participants. (Binanay, C. et al., JAMA, 2005)]]>
Inclusion Criteria Age ‡16 years, current admission for NYHA Class IV heart-failure symptoms, at least one prior admission for exacerbation of CHF within 6 months before randomization, Left ventricular ejection fraction <30% by contrast ventriculography, radionuclide ventriculography, or quantitative echocardiography within 1 year before randomization. documented history of heart failure for ‡3 months, attempted therapy with angiotensin-converting enzyme (ACE) inhibitors and diuretics for ‡3 months before randomization, systolic blood pressure £125 mm Hg, elevated filling pressures, indicated by one symptom AND one physical sign. Exclusion Criteria: Inability to undergo PAC placement within the next 12 hours, Active listing for cardiac transplant, Present or anticipated mechanical ventilation, Present or anticipated mechanical circulatory assist device insertion, including intra-aortic balloon pumps and left ventricular assist devices (LVAD), Any administration of intravenous milrinone within the previous 48 hours, Current administration of intravenous dopamine or dobutamine at >3 mg/kg/min, OR dopamine or dobutamine administration for >24 hours before randomization, Acute myocardial infarction (MI) or cardiac surgery within the last 6 weeks, Current admission for an acute coronary syndrome, including acute MI or unstable angina, Documented moderate-to-severe mitral or aortic stenosis, Anticipated revascularization procedure during the admission, Other planned surgical procedure during the admission, Documented primary pulmonary hypertension, Pulmonary infarction within the past month.]]>