Who needs a swan an evidence based approach

1. 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

2.  Review the Guidelines
 Evaluate the Evidence
 Strategies to Implement the Guidelines
 Refractory Questions
Who Needs A Swan?: An Evidence Based
Approach

3. 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

4.  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

5. 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

6.  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

7. Class I: Review the Evidence

8.  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

9. 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

10. 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

11. 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

12.  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

13. Class III: Review the Evidence – Meta-Analyses
Survival – No Difference with PAC
2005 2013
Shah MR, JAMA, 2005; Rajaram SS, Cochrane Collaboration, 2013

14.  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

15. 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

16. Class IIA: Review the Evidence

17. Class IIA: Advanced Therapy – Left Ventricular
Assist Device
Lund L, Eur J Heart Failure, 2010
RA and PA pressures predict
mortality after LVAD

18. Class IIA: Transplantation
High pre-operative PVR predicts lower survival
after transplantation
ISHLT Registry, 2009

19.  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

20.  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

21. 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)

22.  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

23. Who Needs A Swan?: More Research!

24. Thank You!