Looking over our shoulder while driving down the road: Evaluation of the use of the pulmonary artery catheter in the management of the critically ill

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Looking over our shoulder while driving down the
road Evaluation of the use of the pulmonary
artery catheter in the management of the
critically ill

• Jesse Hall MD
• University of Chicago

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Pulmonary artery catheterization has been around
for a long time!!

• Forssmann performed the first right heart
  catheterization, on himself, in 1929
• Forssmann, Cournand, and RichardsNobel Prize for
  the development of heart catheterization and
  consequent discoveries in cardiac pathophysiology
  (1956)

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Pulmonary artery catheterization has been around
for a long time!!

• Swan HJC, Ganz W, Forrester J, Marcus H, Diamond
  G, Chonette D. Catheterization of the heart in
  man with use of a flow-directed balloon-tipped
  catheter. NEJM 1970283447
• Initially used to assess cardiac function
• For many years
• No clinical trials to assess impact on pt
  outcomes resulting from data derived from
  catheter or interventions resulting from such data

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Pulmonary Artery Catheter

• Data acquired
• Cardiac chamber pressures and waveforms
• RA (2-8), RV (16-24/0-4), PA (16-24/5-12), PCWP
  (5-12)
• Cardiac Output
• Thermodilution
• Fick equation VO2 QT x (CaO2-CvO2)
• SvO2
• SVR 80 x (MAP Pra/ QT) PVR 80 x (Mean PAP
  Ppw/ QT)

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Physiologic parameters should be monitored if

• Sound rationale for perturbations of parameter in
  critical illness
• Parameter can be reliably measured under typical
  conditions
• Monitored variable offers information not
  available via a simpler route and interventions
  can be titrated to the parameter
• Therapy so titrated improves outcome

Chinks in the armor..
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Physician and nurse expertise with these
measurements expertise must be enhanced

• Iberti et al JAMA 1990 2642928
• Iberti et al CCM 1994 221674
• Gnaegi et al CCM 1997 25213

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Determinants of Ptm
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Determinants of Ptm
Pepe and Marini ARRD 126166, 1982
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Given PAC data, clinicians diverge in action taken

• Jain et al ICM 292059, 2003
• Scenarios presented to intensivists with PAC data
  and courses of action, with and without echo data
• Little agreement on selected course of action
  (rarely gt 50 of respondents) and major
  differences with and without echo data

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The PACIs it necessary? Is there any
discernable benefit? How high are the risks?

• Robin ED. The cult of the Swan-Ganz catheter.
  Overuse and abuse of pulmonary flow catheters.
  Ann Intern Med 1985103445

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The effectiveness of right heart catheterization
in the initial care of critically ill patients

• Connors et al JAMA 1996276889
• Retrospective analysis of SUPPORT database
  correlating PAC use and outcome, with attempt to
  correct for confounding effects of severity of
  illness on use of PAC

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Adjustment for treatment selection
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Connors et al JAMA 1996276889

• Problems with this study
• Case matching, not randomized
• Varying clinician management before and after
  placement of PAC?
• Inadequate interpretation of data?
• Prospective trials are needed . . .

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Seeking evidence of efficacy

• Valentine RJ, et al. Effectiveness of PACs in
  aortic surgery a randomized trial. J Vasc Surg
  199827203
• RCT 121 pts
• PAC for perioperative monitoring and hemodynamic
  optimization (tune up) in ICU the night before
  surgery vs. IVF on ward and no PAC

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Pre-op optimization protocoltune up
Valentine RJ, et al.
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• Valentine RJ, et al. Effectiveness of PACs in
  aortic surgery a randomized trial. J Vasc Surg
  199827203
• PAC patients
• More fluid (pre-op, first 24 hrs)
• More adverse intraop events 18 vs. 5 (p 0.02)
• Adverse postop events 25 vs. 17 (p NS)
• No differences in MV duration, ICU LOS, hosp LOS

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Seeking evidence of efficacy

• Richard et al JAMA 2902713, 2003 Multicenter
  trial, enrolling patients with shock, ARDS, or
  both
• RCT
• 676 pts enrolled, assigned to PAC or not (CVP)
• No specific therapy directed by PAC
• No diff in mortality, days free of organ failure,
  renal support, vasoactive drugs, mech vent

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• Richard et al JAMA 20032902713

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Canadian Critical Care Clinical Trials Group
(CCCCTG), Sandham et al, NEJM 2003 3485

• Screened pts gt 60 y/o with ASA class III or IV
  risk scheduled for urgent or elective major
  abdominal, thoracic, vascular, or hip fx surg
• Randomized to PAC or not

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• PAC pts, before surgery, had goals of QO2 of
  550-600 ml/m2 BSA, CI 3.5-4.5 l/min, mean BP 70
  mm Hg, Pcwp lt 18, HR lt 120, Hct gt 27
• Tx used fluid loading, inotropes, vasodilators,
  vasopressors, blood
• Primary outcome in-hospital mortality, secondary
  outcomes mortality at 6 mos, 12 mos, in-hospital
  morbidity

• CCCCTG, NEJM 2003 3485

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• Of 3803 pts, 1994 underwent randomization
• No diff in death rates between std and PAC groups
  (7.7 vs. 7.8 in hospital mortality, 11.9 vs.
  12.6 at 6 mos, 16.1 vs. 17 at 12 mos)
• ?d rate of pulmonary embolism in PAC group

• CCCCTG, NEJM 2003 3485

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• CCCCTG, NEJM 2003 3485

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Harvey S, et al. Assessment of the clinical
effectiveness of pulmonary artery catheters in
management of patients in intensive care
(PAC-Man) a randomised controlled trial. Lancet
2005366472

• RCT
• PAC vs. no PAC
• Timing of insertion and subsequent clinical
  management at discretion of the treating
  clinician
• No difference in hospital mortality (68 vs. 66
  p0.39)
• Complications associated with insertion of a PAC
  in 46 of 486 pts, no fatalities

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Harvey S, et al. Lancet 2005366472
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Binanay C et al. Evaluation study of congestive
heart failure and pulmonary artery
catheterization effectiveness the ESCAPE trial.
JAMA 20052941625

• RCT of 433 patients (enrollment of 500 planned)
• Therapy guided by clinical assessment PAC vs.
  clinical assessment alone
• Target
• Resolution of clinical congestion (additional
  targets of PCWP 15 mm Hg CVP 8 mm Hg)
• No explicit protocol for how to accomplish this
  target
• In both groups reduced symptoms, JVP, edema
• PAC had no impact on days alive and out of hosp
  during 1st 6 months, mortality, days hospitalized
• PAC more adverse events (trial terminated early),
  no fatalities

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FACTT Factorial trial design
Fluid Management
C A T H E T E R
Conservative (n 500)
Liberal (n 500)
PAC (n 500)
250 patients 250 patients 250
patients 250 patients
CVC (n 500)
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MAP lt 60 Low flow by exam or CI lt2.5
Conservative fluid strategy
Furosemide
CVP lt 4 PAOP lt 8
Favors Dry LUNG
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Liberal fluid strategy
Fluids
CI gt 4.5
FiO2 gt 0.7
LUNG
Favors Perfused KIDNEY (organs)
CVP 10-14 PAOP 14-18
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FACTT Protocol drivers

• Protocol drivers measured lt q 4 hr
• MAP, UOP, CI or physical exam, CVP or PAOP
• If the protocol instructs fluid or diuretic for
  oliguria, reassessment occurs within 1 hour.
• If the protocol instructs diuretic for elevated
  CVP or PAOP, reassessment occur, within 4 hours.

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Cumulative fluid balance
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PAC vs CVC, NEJM May 2006
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PAC vs CVC, NEJM May 2006
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NEJM 20063542213
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Pulmonary Artery Catheter

• Summarizing multiple prospective trials
• No benefit for high risk surgery patients
• No benefit when used as routine primary monitor
  without a treatment protocol
• No benefit when linked to a protocol
• No benefit in general ICU use
• No benefit for patients with CHF, AHRF

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Effects of MV on BP and CO

• MV decreases RV filling and ejection
• After a delay (transit through the lungs), PP
  falls
• ?PP should be greater when RV and LV operate on
  the steep portion of the Starling curve

Michard F, et al. AJRCCM 2000162134
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Assessing Volume Responsiveness

• Septic shock patients
• Passive on MV
• 500mL colloid bolus
• Volume responder
• gt 15 ? CI
• ?PP() 100(Ppmax -Ppmin)/(Ppmax  Ppmin)/2
• ?PP of 13
• Distinguished
• Volume responder vs. nonresponder
• Sens 94 Spec 96

Michard F, et al. AJRCCM 2000162134
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Hypovolemic ShockFluid responsiveness

• Positive pressure ventilation (and completely
  passive)
• ?PP gt 13 ? IVF bolus likely to improve
  perfusion
• Spontaneously breathing
• ?Pra gt 1 mmHg ? IVF bolus likely to improve
  perfusion1

1. Magder S, et.al J Crit Care 776, 1992

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Can you estimate ?PP without an arterial catheter?
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Rivers E et al. NEJM 20013451368Severe
sepsis/septic shock

• Early goal directed therapyoften hypovolemic on
  presentation
• 263 pts with severe sepsis/septic shock,
  randomized to
• CVP 8-12 (500 ml q 30 min), MAP 65-90, urine gt
  0.5 ml/kg/hr (control)
• Above plus ScvO2 gt 70 (goal directed)
• IVF, dobut, PRBC, sedation /- paralysis if
  intubated
• Earlyfirst six hours in ER

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• Rivers E et al. NEJM 20013451368

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Can you determine CVP without a CVP catheter?

• Vinayak AG, et al. Usefulness of the External
  Jugular Vein Examination in Detecting Abnormal
  Central Venous Pressure in Critically Ill
  Patients. Arch Int Med 20061662132
• 35 ICU pts (16 intubated)
• EJ vein to measure CVP vs. indwelling catheter
• CVP by EJ measured in cm H2O (1 mm Hg  1.36 cm
  H2O)
• Blinded evalCategorized
• Low (lt 5 cm H2O)
• Normal (6-9 cm H2O)
• High (10 cm H2O)

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Vinayak AG, et al. Arch Int Med 20061662132
Low CVP
High CVP
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Other potential endpoints to follow volume
status/adequacy of tissue perfusion

• Clinical exam
• End organ perfusion
• Acid-base/lactate
• Urine output
• Mental status
• CVP
• ?PP
• Echocardiography

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Conclusions

• No support for use of PAC for any group for
  routine monitoring
• Remains a diagnostic tool for highly individual
  patient circumstances
• Even in this context, alternative measures and
  even routine clinical information may be
  preferable