Confirm pulmonary arterial hypertension
with right heart catheterization

	Hemodynamic changes correlate with disease progression.1,2
	RHC confirms a PAH diagnosis and can help determine disease severity.1
	Hemodynamics are important prognostic indicators in PAH.1

Clinical definition of pulmonary arterial hypertension

—ACCF/AHA 2009 Expert Consensus Document on Pulmonary Hypertension

Hemodynamic measurements, calculations, and normal values
		Normal hemodynamic values at rest
Measurement		Average (mm Hg)	Range (mm Hg)
RAP3	a wave v wave	6 5	2-7 2-7
mRAP3	Elevated mRAP may be indicative of right ventricular failure3	3	1-5
RVP3	peak systolic end diastolic	25 4	15-30 1-7
PAP3	peak systolic end diastolic	25 9	15-30 4-12
mPAP1,4	Reduce variability by consistently measuring pressures over 2 to 3 respiratory cycles at end-exhalation1	14	8-20
CO3,5	Fick calculation*		4-8 L/min
CI6	Obtained by Fick calculation or thermodilution		2.5-4.2 L/min/m2
PCWP3	Confirm that PCWP is not a damped PA pressure by using a precise a and v waveform timed against ECG or LV pressure7	9	4-12
LAP3	a wave v wave	10 12	4-16 6-21
LVP3	peak systolic end diastolic	130 8	90-140 5-12

	Normal hemodynamic values at rest
Vascular resistance	Average3 (dyn•sec/cm5)	Range3 (dyn•sec/cm5)
SVR	1100	700-1600	SVR = 80 (Aom – RAm) Qs3
TPR	200	100-300	Should be used primarily in patients in whom measurement of LA or PCWP is not possible8
PVR	70	20-130	PVR = 80 (mPAP–PCWP)/CO9

*Fick calculation3: CO (L/min) =	O2 consumption (mL/min)
	Arteriovenous O2 difference (vol %) x 1.36 x Hgb x10

Note: All measurement should be conducted at end-exhalation.¹ Individual hospital guidelines can vary for hemodynamic measurements and calculations needed to diagnose PAH with right heart catheterization. This chart is for reference only and is not intended to provide medical advice or to replace individual hospital guidelines.

Ao_m mean aortic pressure; CI cardiac index; CO cardiac output; Hgb hemoglobin; LAP left atrial pressure; LVP left ventricular pressure; mPAP mean pulmonary arterial pressure; mRAP mean right atrial pressure; PAP pulmonary arterial pressure; PASP pulmonary arterial systolic pressure; PCWP pulmonary capillary wedge pressure; PVR pulmonary vascular resistance; Q_s systemic blood flow; RA_m mean right atrial pressure; RAP right atrial pressure; RHC right heart catheterization; RVP right ventricular pressure; RVEF right ventricular ejection fraction; SVR systemic vascular resistance; TPR total pulmonary resistance.

Tracleer is indicated for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) in patients with WHO Class II-IV symptoms, to improve exercise ability and decrease the rate of clinical worsening. Patients with WHO Class II symptoms showed reduction in the rate of clinical deterioration and a trend for improvement in walk distance. Physicians should consider whether these potential benefits are sufficient to offset liver injury in WHO Class II patients, which may preclude future use as their disease progresses.

Important safety information

Because of the associated risks, Tracleer may be prescribed only through the Tracleer Access Program.

Potential for serious liver injury (including, after prolonged treatment, rare cases of liver failure and unexplained hepatic cirrhosis in a setting of close monitoring)—Liver monitoring of all patients is essential prior to initiation of treatment and monthly thereafter.

High potential for major birth defects—Pregnancy must be excluded and prevented through the use of reliable forms of birth control; monthly pregnancy tests should be obtained.

Contraindicated for use with cyclosporine A and glyburide.

Please see full prescribing information including BOXED WARNING.

Review determination of functional class status

1. McLaughlin VV, Archer SL, Badesch DB, et al. ACCF/AHA 2009 expert consensus document on pulmonary hypertension. J Am Coll Cardiol. 2009;53:1573-1619.
2. Rich S, McLaughlin VV. Pulmonary hypertension. In: Libby P, Bonow RO, Mann DL, Zipes DE, eds. Braunwald's Heart Disease. 2 vols. 8th ed. Philadelphia, PA: Saunders Elsevier; 2008:1883-1914.
3. Davidson CJ, Bonow RO. Cardiac catheterization. In: Libby P, Bonow RO, Mann DL, Zipes DE. Braunwald's Heart Disease. 2 vols. 8th ed. Philadelphia, PA: Saunders Elsevier; 2008:439-463.
4. Badesch DB, Champion HC, Sanchez MA, et al. Diagnosis and assessment of pulmonary arterial hypertension. J Am Coll Cardiol. 2009;54(suppl S):S55-S66.
5. Cardiovascular Tests and Procedures: Cardiac Catheterization. Merck Manual Professional website. http://www.merck.com/mmpe/sec07/ch070/ch070b.html. Accessed February 2, 2010.
6. Kaluski E, Shah M, Korbrin I, et al. Right heart catheterization: indications, technique, safety, measurements, and alternatives. Heart Drug. 2003;3:225-235.
7. Kern MJ, ed. The Cardiac Catheterization Handbook. 4th ed. Philadelphia, PA: Mosby; 2003:135, 158-159.
8. Grossman W. Blood flow measurement: cardiac output and vascular resistance. In: Baim DS, ed. Grossman's Cardiac Catheterization, Angiography, and Intervention. 7th ed. Philadelphia, PA: Lippincott Williams & Wilkins; 2006:148-162.
9. Galiè N, Rubin LJ, Hoeper MM, et al. Treatment of patients with mildly symptomatic pulmonary arterial hypertension with bosentan (EARLY study): a double-blind, randomised controlled trial. Lancet. 2008;371:2093-2100.