Evaluation study of congestive heart failure and pulmonary artery catheterization effectiveness

James A. Hill, Daniel F. Pauly, Debra R. Olitsky, Stuart Russell, Christopher M. O'Connor, Beth Patterson, Uri Elkayam, Salman Khan, Lynne W. Stevenson, Kimberly Brooks, Lynne Wagoner, Ginger Conway, Todd Koelling, Carol Van Huysen, Joshua Hare, Elayne Breton, Kirkwood F. Adams, Jana Glotzer, Gregg Fonarow, Michele HamiltonJulie Sorg, Mark Drazner, Shannon Hoffman, Leslie W. Miller, Judith A. Graziano, Mary Ellen Berman, Robert Frantz, Karen Hartman, Carl V. Leier, William T. Abraham, Laura Yamokoski, Thomas G. DiSalvo, Janice Camuso, Mihai Gheorghiade, Karen Fachet, Alain Heroux, Jin Kim Soo, J. Wayne Warnica, Jane Grant, Mian Hasan, Lydia Withrow, James Young, Barbara Gus, Javed Butler, Laurie Hawkins, Barry K. Rayburn, Jessica Robinson, Ileana L. Pina, Lori Shelby, Joseph Rogers, Heidi Craddock, Melvin Tonkon, Shane Miller, Teresa DeMarco, Debra Lau, Maryl Johnson, Cassondra Vander Ark

Research output: Contribution to journalArticle

806 Citations (Scopus)

Abstract

Context: Pulmonary 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. Objective: To determine whether PAC use is safe and improves clinical outcomes in patients hospitalized with severe symptomatic and recurrent heart failure. Design, Setting, and Participants: The 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 Measures: The 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. Results: Severity 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. 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 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.

Original languageEnglish (US)
Pages (from-to)1625-1633
Number of pages9
JournalJournal of the American Medical Association
Volume294
Issue number13
DOIs
StatePublished - Oct 5 2005
Externally publishedYes

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Swan-Ganz Catheterization
Pulmonary Artery
Catheters
Heart Failure
Confidence Intervals
Mortality
Hospitalization
Therapeutics
Odds Ratio
Quality of Life
Exercise
Blood Pressure
Pulmonary Wedge Pressure
Venous Pressure
Atrial Pressure
Survival
Random Allocation
Stroke Volume
Signs and Symptoms
Urea

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Hill, J. A., Pauly, D. F., Olitsky, D. R., Russell, S., O'Connor, C. M., Patterson, B., ... Ark, C. V. (2005). Evaluation study of congestive heart failure and pulmonary artery catheterization effectiveness. Journal of the American Medical Association, 294(13), 1625-1633. https://doi.org/10.1001/jama.294.13.1625

Evaluation study of congestive heart failure and pulmonary artery catheterization effectiveness. / Hill, James A.; Pauly, Daniel F.; Olitsky, Debra R.; Russell, Stuart; O'Connor, Christopher M.; Patterson, Beth; Elkayam, Uri; Khan, Salman; Stevenson, Lynne W.; Brooks, Kimberly; Wagoner, Lynne; Conway, Ginger; Koelling, Todd; Van Huysen, Carol; Hare, Joshua; Breton, Elayne; Adams, Kirkwood F.; Glotzer, Jana; Fonarow, Gregg; Hamilton, Michele; Sorg, Julie; Drazner, Mark; Hoffman, Shannon; Miller, Leslie W.; Graziano, Judith A.; Berman, Mary Ellen; Frantz, Robert; Hartman, Karen; Leier, Carl V.; Abraham, William T.; Yamokoski, Laura; DiSalvo, Thomas G.; Camuso, Janice; Gheorghiade, Mihai; Fachet, Karen; Heroux, Alain; Soo, Jin Kim; Warnica, J. Wayne; Grant, Jane; Hasan, Mian; Withrow, Lydia; Young, James; Gus, Barbara; Butler, Javed; Hawkins, Laurie; Rayburn, Barry K.; Robinson, Jessica; Pina, Ileana L.; Shelby, Lori; Rogers, Joseph; Craddock, Heidi; Tonkon, Melvin; Miller, Shane; DeMarco, Teresa; Lau, Debra; Johnson, Maryl; Ark, Cassondra Vander.

In: Journal of the American Medical Association, Vol. 294, No. 13, 05.10.2005, p. 1625-1633.

Research output: Contribution to journalArticle

Hill, JA, Pauly, DF, Olitsky, DR, Russell, S, O'Connor, CM, Patterson, B, Elkayam, U, Khan, S, Stevenson, LW, Brooks, K, Wagoner, L, Conway, G, Koelling, T, Van Huysen, C, Hare, J, Breton, E, Adams, KF, Glotzer, J, Fonarow, G, Hamilton, M, Sorg, J, Drazner, M, Hoffman, S, Miller, LW, Graziano, JA, Berman, ME, Frantz, R, Hartman, K, Leier, CV, Abraham, WT, Yamokoski, L, DiSalvo, TG, Camuso, J, Gheorghiade, M, Fachet, K, Heroux, A, Soo, JK, Warnica, JW, Grant, J, Hasan, M, Withrow, L, Young, J, Gus, B, Butler, J, Hawkins, L, Rayburn, BK, Robinson, J, Pina, IL, Shelby, L, Rogers, J, Craddock, H, Tonkon, M, Miller, S, DeMarco, T, Lau, D, Johnson, M & Ark, CV 2005, 'Evaluation study of congestive heart failure and pulmonary artery catheterization effectiveness', Journal of the American Medical Association, vol. 294, no. 13, pp. 1625-1633. https://doi.org/10.1001/jama.294.13.1625
Hill, James A. ; Pauly, Daniel F. ; Olitsky, Debra R. ; Russell, Stuart ; O'Connor, Christopher M. ; Patterson, Beth ; Elkayam, Uri ; Khan, Salman ; Stevenson, Lynne W. ; Brooks, Kimberly ; Wagoner, Lynne ; Conway, Ginger ; Koelling, Todd ; Van Huysen, Carol ; Hare, Joshua ; Breton, Elayne ; Adams, Kirkwood F. ; Glotzer, Jana ; Fonarow, Gregg ; Hamilton, Michele ; Sorg, Julie ; Drazner, Mark ; Hoffman, Shannon ; Miller, Leslie W. ; Graziano, Judith A. ; Berman, Mary Ellen ; Frantz, Robert ; Hartman, Karen ; Leier, Carl V. ; Abraham, William T. ; Yamokoski, Laura ; DiSalvo, Thomas G. ; Camuso, Janice ; Gheorghiade, Mihai ; Fachet, Karen ; Heroux, Alain ; Soo, Jin Kim ; Warnica, J. Wayne ; Grant, Jane ; Hasan, Mian ; Withrow, Lydia ; Young, James ; Gus, Barbara ; Butler, Javed ; Hawkins, Laurie ; Rayburn, Barry K. ; Robinson, Jessica ; Pina, Ileana L. ; Shelby, Lori ; Rogers, Joseph ; Craddock, Heidi ; Tonkon, Melvin ; Miller, Shane ; DeMarco, Teresa ; Lau, Debra ; Johnson, Maryl ; Ark, Cassondra Vander. / Evaluation study of congestive heart failure and pulmonary artery catheterization effectiveness. In: Journal of the American Medical Association. 2005 ; Vol. 294, No. 13. pp. 1625-1633.
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title = "Evaluation study of congestive heart failure and pulmonary artery catheterization effectiveness",
abstract = "Context: Pulmonary 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. Objective: To determine whether PAC use is safe and improves clinical outcomes in patients hospitalized with severe symptomatic and recurrent heart failure. Design, Setting, and Participants: The 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 Measures: The 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. Results: Severity 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. 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 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.",
author = "Hill, {James A.} and Pauly, {Daniel F.} and Olitsky, {Debra R.} and Stuart Russell and O'Connor, {Christopher M.} and Beth Patterson and Uri Elkayam and Salman Khan and Stevenson, {Lynne W.} and Kimberly Brooks and Lynne Wagoner and Ginger Conway and Todd Koelling and {Van Huysen}, Carol and Joshua Hare and Elayne Breton and Adams, {Kirkwood F.} and Jana Glotzer and Gregg Fonarow and Michele Hamilton and Julie Sorg and Mark Drazner and Shannon Hoffman and Miller, {Leslie W.} and Graziano, {Judith A.} and Berman, {Mary Ellen} and Robert Frantz and Karen Hartman and Leier, {Carl V.} and Abraham, {William T.} and Laura Yamokoski and DiSalvo, {Thomas G.} and Janice Camuso and Mihai Gheorghiade and Karen Fachet and Alain Heroux and Soo, {Jin Kim} and Warnica, {J. Wayne} and Jane Grant and Mian Hasan and Lydia Withrow and James Young and Barbara Gus and Javed Butler and Laurie Hawkins and Rayburn, {Barry K.} and Jessica Robinson and Pina, {Ileana L.} and Lori Shelby and Joseph Rogers and Heidi Craddock and Melvin Tonkon and Shane Miller and Teresa DeMarco and Debra Lau and Maryl Johnson and Ark, {Cassondra Vander}",
year = "2005",
month = "10",
day = "5",
doi = "10.1001/jama.294.13.1625",
language = "English (US)",
volume = "294",
pages = "1625--1633",
journal = "JAMA - Journal of the American Medical Association",
issn = "0002-9955",
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TY - JOUR

T1 - Evaluation study of congestive heart failure and pulmonary artery catheterization effectiveness

AU - Hill, James A.

AU - Pauly, Daniel F.

AU - Olitsky, Debra R.

AU - Russell, Stuart

AU - O'Connor, Christopher M.

AU - Patterson, Beth

AU - Elkayam, Uri

AU - Khan, Salman

AU - Stevenson, Lynne W.

AU - Brooks, Kimberly

AU - Wagoner, Lynne

AU - Conway, Ginger

AU - Koelling, Todd

AU - Van Huysen, Carol

AU - Hare, Joshua

AU - Breton, Elayne

AU - Adams, Kirkwood F.

AU - Glotzer, Jana

AU - Fonarow, Gregg

AU - Hamilton, Michele

AU - Sorg, Julie

AU - Drazner, Mark

AU - Hoffman, Shannon

AU - Miller, Leslie W.

AU - Graziano, Judith A.

AU - Berman, Mary Ellen

AU - Frantz, Robert

AU - Hartman, Karen

AU - Leier, Carl V.

AU - Abraham, William T.

AU - Yamokoski, Laura

AU - DiSalvo, Thomas G.

AU - Camuso, Janice

AU - Gheorghiade, Mihai

AU - Fachet, Karen

AU - Heroux, Alain

AU - Soo, Jin Kim

AU - Warnica, J. Wayne

AU - Grant, Jane

AU - Hasan, Mian

AU - Withrow, Lydia

AU - Young, James

AU - Gus, Barbara

AU - Butler, Javed

AU - Hawkins, Laurie

AU - Rayburn, Barry K.

AU - Robinson, Jessica

AU - Pina, Ileana L.

AU - Shelby, Lori

AU - Rogers, Joseph

AU - Craddock, Heidi

AU - Tonkon, Melvin

AU - Miller, Shane

AU - DeMarco, Teresa

AU - Lau, Debra

AU - Johnson, Maryl

AU - Ark, Cassondra Vander

PY - 2005/10/5

Y1 - 2005/10/5

N2 - Context: Pulmonary 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. Objective: To determine whether PAC use is safe and improves clinical outcomes in patients hospitalized with severe symptomatic and recurrent heart failure. Design, Setting, and Participants: The 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 Measures: The 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. Results: Severity 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. 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 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.

AB - Context: Pulmonary 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. Objective: To determine whether PAC use is safe and improves clinical outcomes in patients hospitalized with severe symptomatic and recurrent heart failure. Design, Setting, and Participants: The 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 Measures: The 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. Results: Severity 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. 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 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.

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JO - JAMA - Journal of the American Medical Association

JF - JAMA - Journal of the American Medical Association

SN - 0002-9955

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