ESCAPE published: PAC-based acute-HF management shouldn't be routine

October 04, 2005

Chicago, IL - Therapy of acute heart failure guided by pulmonary-artery catheter (PAC) hemodynamic monitoring doesn't enhance or diminish survival compared with management based on clinical signs, although it may improve outcomes in some situations and doesn't necessarily harm, according to a report in the October 5, 2004 issue of the Journal of the American Medical Association[1].

"There is no indication for routine use of PACs to adjust therapy during hospitalization for decompensation of chronic heart failure," the authors write. However, "it seems probable that there are some patients and some therapies that yield improved outcome with PAC monitoring and others with counterbalancing deleterious effects." The Evaluation Study of Congestive Heart Failure and Pulmonary Artery Catheterization Effectiveness (ESCAPE) also highlights a poor understanding of when and how to use PAC-guided therapy in acute HF, its investigators say.

 
This provides reassuring information that to treat the patient in a non-ICU setting, without a PAC, is justified and based on evidence.
 

Because the PAC isn't a therapy itself, but rather a tool for guiding therapy, "its impact really depends on what one does with the information," lead investigator Dr Lynne W Stevenson (Brigham and Women's Hospital, Boston, MA) said to heart wire . "Most patients who are hospitalized with heart failure will have a good result if their course is monitored by the usual careful clinical assessment." Candidates for PAC-guided therapy, she proposed, would include those who don't respond to clinically guided first-line therapy or are repeatedly hospitalized for HF.

ESCAPE, sponsored by the US National Heart, Lung, and Blood Institute, was presented previously at the American Heart Association 2004 Scientific Sessions and reported by heart wire .

"A negative trial is sometimes useful," observed Dr Randall C Starling (Cleveland Clinic Foundation, OH). Previously for patients like those entered, he told heart wire , "we really didn't know whether outcomes would be better with or without a pulmonary-artery catheter. This provides reassuring information that to treat the patient in a non-ICU setting, without a PAC, is justified and based on evidence."

The trial, conducted at 26 North American centers, randomized 433 patients with severe, symptomatic HF despite standard medical therapy to treatment guided by a PAC or clinical examination. Right-atrial and pulmonary capillary wedge pressure treatment goals, but not use of specific drugs, were prespecified for all patients. Inotropes were explicitly discouraged, the group writes.

 
A hospital without a specialized HF center that has a sick patient on their hands who isn't responding well to conventional therapy is better served by referring that patient to a specialized heart-failure center.
 

Both groups showed greatly improved symptoms and reduced jugular venous pressure and edema. But no difference was seen in the primary end point of out-of-hospital days alive over six months, which reached 133 days for PAC-guided therapy and 135 days in the control group. Nor were there mortality differences in hospital or at 30 days. No deaths were considered related to PAC use. However, six-minute-walk distance, peak oxygen consumption, and quality-of-life scores among PAC-managed patients trended toward improvement during the follow-up. No patient subgroup appeared to have a significant outcome advantage with either strategy.

The rates of in-hospital adverse events, predominantly infection, were 22% for PAC-managed patients and 11.5% among controls (p=0.04). But there was no difference in in-hospital mortality, and the adverse-event rate equalized by six months, Stevenson observed. All ESCAPE centers were experienced in PAC-guided therapy, but there was a trend toward better outcomes at centers with higher enrollment.

Those observations support a highly selective use of PAC-guided therapy, according to Stevenson. "As with any procedure, it is associated with some risks, and those risks appear more justified at experienced centers for patients who continue after routine therapy to have persistent symptoms that limit their quality of life."

Starling said he personally believes that a hospital without a specialized HF center that has "a sick patient on their hands who isn't responding well to conventional therapy is better served by referring that patient to a specialized heart-failure center," where decisions on whether to use PAC-guided therapy can be more appropriately made.



PAC use questioned across clinical settings

A meta-analysis of 13 available randomized controlled trials in a range of clinical settings, including the ESCAPE trial, found no significant effect of PAC-based management on mortality or length of hospitalization [2].

None of the trials showed "a sufficiently positive effect of the PAC on outcomes," suggesting it "should not be a standard of care," according to Dr Monica R Shah (Columbia University, New York, NY) and colleagues, all of whom played leading roles in the ESCAPE trial. Their meta-analysis, published in JAMA simultaneously with ESCAPE, provides "broader confirmation" of that trial's results, they write.

 
Should there be a positive result attributable to PAC in this trial, a specific niche for this technology may remain in critical care.
 

PAC monitoring is "a diagnostic tool, similar to a chest radiograph or an echocardiogram" that needs an effective therapy to guide before it can be expected to improve outcomes, Shah and colleagues write. Their findings highlight a lack of consensus about therapeutic goals and how to use the PAC, as well as the dearth of effective evidence-based therapies for acutely ill patients, according to the group.

In his editorial accompanying the meta-analysis and ESCAPE papers [3], critical-care expert Dr Jesse B Hall (University of Chicago, IL) notes that an ongoing trial is testing the PAC's role in management in acute respiratory distress syndrome, also comparing "fluid-conservative" and "fluid-liberal" treatment approaches. Compared with any PAC trial yet reported, he writes, this one alone is capable of evaluating the impact of PAC-based management as well as the treatment strategy guided by hemodynamic monitoring. "Should there be a positive result attributable to PAC in this trial, a specific niche for this technology may remain in critical care."


Comments

3090D553-9492-4563-8681-AD288FA52ACE
Comments on Medscape are moderated and should be professional in tone and on topic. You must declare any conflicts of interest related to your comments and responses. Please see our Commenting Guide for further information. We reserve the right to remove posts at our sole discretion.
Post as:

processing....