Research from JAMA — Evaluation Study of Congestive Heart Failure and Pulmonary Artery Catheterization
Effectiveness — The ESCAPE Trial — ContextPulmonary artery catheters (PACs) have been used to guide therapy in
multiple settings, but recent studies have raised concerns that PACs may lead
to increased mortality in hospitalized patients.ObjectiveTo determine whether PAC use is safe and improves clinical outcomes
in patients hospitalized with severe symptomatic and recurrent heart failure.Design, Setting, and ParticipantsThe Evaluation Study of Congestive Heart Failure and Pulmonary Artery
Catheterization Effectiveness (ESCAPE) was a randomized controlled trial of
433 patients at 26 sites conducted from January 18, 2000, to November 17,
2003. Patients were assigned to receive therapy guided by clinical assessment
and a PAC or clinical assessment alone. The target in both groups was resolution
of clinical congestion, with additional PAC targets of a pulmonary capillary
wedge pressure of 15 mm Hg and a right atrial pressure of 8 mm Hg. Medications
were not specified, but inotrope use was explicitly discouraged.Main Outcome MeasuresThe primary end point was days alive out of the hospital during the
first 6 months, with secondary end points of exercise, quality of life, biochemical,
and echocardiographic changes.ResultsSeverity of illness was reflected by the following values: average left
ventricular ejection fraction, 19%; systolic blood pressure, 106 mm Hg; sodium
level, 137 mEq/L; urea nitrogen, 35 mg/dL (12.40 mmol/L); and creatinine,
1.5 mg/dL (132.6 µmol/L). Therapy in both groups led to substantial reduction
in symptoms, jugular venous pressure, and edema. Use of the PAC did not significantly
affect the primary end point of days alive and out of the hospital during
the first 6 months (133 days vs 135 days; hazard ratio [HR], 1.00 [95% confidence
interval {CI}, 0.82-1.21]; P = .99), mortality
(43 patients [10%] vs 38 patients [9%]; odds ratio [OR], 1.26 [95% CI, 0.78-2.03]; P = .35), or the number of days hospitalized
(8.7 vs 8.3; HR, 1.04 [95% CI, 0.86-1.27]; P = .67).
In-hospital adverse events were more common among patients in the PAC group
(47 [21.9%] vs 25 [11.5%]; P = .04). There
were no deaths related to PAC use, and no difference for in-hospital plus
30-day mortality (10 [4.7%] vs 11 [5.0%]; OR, 0.97 [95% CI, 0.38-2.22]; P = .97). Exercise and quality of life end points
improved in both groups with a trend toward greater improvement with the PAC,
which reached significance for the time trade-off at all time points after
randomization.ConclusionsTherapy 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 PAC. Addition of the PAC to careful clinical assessment
increased anticipated adverse events, but did not affect 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 patients.