Who Needs a Swan?:

An Evidence Based Approach

Monica R. Shah, MD

Financial disclosures: None

American College of Cardiology Session:

Treatment Strategies for Hospitalized Heart Failure Patients

March 16, 2015

Review the Guidelines

Evaluate the Evidence

Strategies to Implement the Guidelines

Refractory Questions

Who Needs A Swan?: An Evidence Based

Approach

The Evidence Based Medicine Triad

Best External

Evidence

Individual

Clinical

Expertise

Patient Values &

Expectations Evidence Based

Medicine

www.cochrance.org/about-us/evidence-based-health-care

Classification of Recommendations Class I – Intervention is useful

Class II – Questions about usefulness of intervention

- IIA – weight of evidence/opinion in favor

- IIB – less well established by evidence/opinion

Class III – Intervention is harmful

Level of Evidence A – Multiple clinical trials

B – Single randomized trial or non-randomized studies

C – Expert opinion

Guidelines: Evidence Based Scoring System

Circulation; 2006; 114: 1761-1791

Who Needs a Swan?: Review the Guidelines

Yancy C, et al. J Am Coll Cardiol & Circ, 2013;

Hunt S, et al. J Am Coll Card & Circ, 2009

Class I

Invasive hemodynamic (HD) monitoring should

be performed in patients with respiratory distress

or in patients with clinical evidence of impaired

perfusion in whom the adequacy or excess of

intra-cardiac filling pressures cannot be

determined from clinical assessment

Level of Evidence C

Who Needs a Swan?: Review the Guidelines

Yancy C, et al. J Am Coll Cardiol & Circ, 2013;

Hunt S, et al. J Am Coll Card & Circ, 2009

Class I: Review the Evidence

Patient decompensating and/or unstable

Respiratory distress, cardiogenic shock

Need to make decisions about interventions

Inotropes and/or urgent mechanical

support/cardiac transplant

Aggressive diuretics and/or more advanced renal

replacement therapies

Class I: Implementing the Guidelines

Who Needs A Swan?: Review the Guidelines

Class III

Routine use of invasive HD monitoring in

normotensive patients with acute decompensated

HF and congestion with symptomatic response to

diuretics and vasodilators is not recommended

Level of Evidence B

Yancy C, et al. J Am Coll Cardiol & Circ, 2013;

Hunt S, et al. J Am Coll Card & Circ, 2009

Class III: Review the Evidence

ESCAPE Investigators, JAMA, 2005; Shah MR, JAMA, 2005;

Rajaram SS, Cochrane Collaboration, 2013

RCT, n=433

13 RCT;

n=5686

13 RCT;

n=5051

Review the Evidence: ESCAPE

ESCAPE

• n=433

• NYHA class IV HF,

equipoise about

pulmonary

artery catheter (PAC)

• Intervention – PAC vs.

Clinical Assessment

• OR 1.0

(95% CI 0.82-1.21;

p=0.99)

ESCAPE Investigators. JAMA 2005;294:1625-1633

PACs are not useful in this population

Patients who needed a PAC were excluded

PAC is a diagnostic tool – choice of therapies

may have influenced outcome

~40% of patients in PAC Arm received inotropes

Short-term improvements in HD unlikely to have

long-term effects unless maintained in the

outpatient setting

Improving HF outcomes requires a continuum of care

ESCAPE: Results Debated

Class III: Review the Evidence – Meta-Analyses

Survival – No Difference with PAC

2005 2013

Shah MR, JAMA, 2005; Rajaram SS, Cochrane Collaboration, 2013

Use of invasive HD monitoring is not

indicated for routine management of

decompensated HF

But there are still some key “refractory

questions”

Class III: Implementing the Guidelines

Who Needs A Swan?: Review the Guidelines

Class IIA Invasive HD monitoring can be useful for carefully

selected patients with acute HF who have persistent symptoms despite empiric adjustment of standard therapies, and:

- Whose fluid status, perfusion, or systematic or pulmonary vascular resistance are uncertain

- Whose SBP remains low or is associated with symptoms, despite initial therapy

- Whose renal function is worsening with therapy

- Who require parenteral vasoactive agents

- Who may need consideration for advanced therapy or transplantation

Level of Evidence C

Yancy C, et al. J Am Coll Cardiol & Circ, 2013;

Hunt S, et al. J Am Coll Card & Circ, 2009

Class IIA: Review the Evidence

Class IIA: Advanced Therapy – Left Ventricular

Assist Device

Lund L, Eur J Heart Failure, 2010

RA and PA pressures predict

mortality after LVAD

Class IIA: Transplantation

High pre-operative PVR predicts lower survival

after transplantation

ISHLT Registry, 2009

Difficult to assess volume status Obese patients

Significant pulmonary hypertension or RV dysfunction complicating management & adjustment of therapies

Worsening renal function – guide decisions about intervention Cardio-renal syndrome – diuretics, other

decongestive strategies

Poor perfusion – inotropes, advanced therapies

Evaluate & select optimal candidates for LVAD/transplant

Class IIA: Implementing the Guidelines

Can HD monitoring help us better identify and treat persistent congestion prior to discharge?

Would inpatient HD monitoring be more effective if followed by outpatient HD monitoring?

Could we randomize acute HF patients with Class IIA or III indications to - Physician decision inpatient PAC & outpatient HD

monitoring

- Physician decision inpatient PAC & no outpatient HD monitoring

Who Needs A Swan?: Refractory Questions

Shah MR, J Card Fail, 2004

Next Steps: Integrating Inpatient & Outpatient

HD Monitoring?

CHAMPION

• n=550

• Ambulatory NYHA class III,

≥1 HF hosp. in past year

• Standard care guided by

implantable HD device

measurement

vs. standard care

• Primary Endpoint –

Rate of HF Hosp.

Abraham W, Lancet, 2011

OR 0.72 (95% CI 0.6-0.75; p=0.0002)

Decision about use of HD monitoring more clear at the extremes

We still have to use both data & clinical judgment for many of our HF patients

Perhaps the next study of HD monitoring will span both the highly controlled inpatient setting of the hospital

AND

the highly variable outpatient setting of daily life

Who Needs a Swan?: Final Thoughts

Who Needs A Swan?: More Research!

Thank You!