A Hemodynamically Oriented Echocardiography-Based Strategy in the Treatment of Congestive Heart Failure
A Hemodynamically Oriented Echocardiography-Based Strategy in the Treatment of Congestive Heart Failure
The purpose of this study was to compare two strategies in the treatment of outpatients with
 heart failure. We hypothesized that an individualized treatment strategy based on the
 availability of hemodynamic data from non-invasive testing would be feasible and
 significantly reduce morbidity compared to the conventional clinically oriented treatment of
 heart failure outpatients.
Clinical strategies aiming at achieving an optimal hemodynamic profile have been advocated
 for the management of congestive heart failure. Non-invasive estimates, based on
 echocardiographic evaluations, might identify outpatients that could benefit from additional
 pharmacological therapy. Based on this assumption we conducted a single-center, prospective,
 randomized, open-label, blinded endpoint evaluation clinical trial comparing an
 echocardiography-guided strategy aimed at achieving a near-normal hemodynamic profile and the
 conventional clinically-oriented strategy for congestive heart failure management.

 Echocardiography-guided strategy. Patients allocated to the echocardiography-guided strategy
 underwent sequential cardiac ultrasound examinations to evaluate hemodynamic-derived
 parameters. M-mode and two-dimensional color Doppler echocardiography was performed by an
 experienced cardiologist using commercially available ultrasound equipments (ATL HDI 5000,
 Bothel, WA, USA). Echocardiographic parameters were evaluated according to standard
 recommendations of the American Society of Echocardiography. For each measurement, 3-5
 consecutive cardiac cycles were measured and averaged. Hemodynamic parameters were determined
 according to previously validated protocols. In brief, pulmonary artery systolic pressure was
 estimated as the sum of the estimated right atrial pressure and the pressure gradient between
 the right ventricle and right atria. Right atrial pressure was estimated by measuring the
 inferior vena cava diameter and its degree of collapsibility during inspiration. Cardiac
 output was determined by multiplying heart rate by left ventricular systolic volume. Left
 ventricular systolic volume was estimated by multiplying the time-velocity integral of the
 left ventricular outflow by the estimated left ventricular outflow area. Systemic vascular
 resistance was calculated using standard hemodynamic formulas, incorporating cardiac output
 and mean arterial pressure estimations. Systemic vascular resistance and cardiac output were
 indexed by body surface area. Each patient assigned to the echocardiography-guided strategy
 underwent three consecutive echocardiograms separated by four-week periods and a final
 echocardiogram at 6 months. Following each test, all patients were reevaluated by physicians
 from the heart failure team. Pharmacological therapy was then guided according to a
 pre-defined protocol based on hemodynamic estimates. Firstly, whenever elevated right-sided
 filling pressures were detected loop diuretic therapy was incremented irrespective of the
 presence of clinical signs and symptoms of pulmonary and/or systemic congestion. Afterwards,
 whenever raised systemic vascular resistance was identified, additional vasodilator therapy
 was incorporated or optimized, as long as systolic arterial pressure was equal or greater
 than 90 mmHg.

 Clinically-guided strategy. Therapeutic decisions for patients assigned to the conventional
 treatment were based on recommendations from international clinical practice guidelines.
 Angiotensin converting enzyme inhibitors and beta-blockers use and optimization were
 encouraged. Standard non-pharmacological counseling was also provided by CHF trained nurses
 during the first month of follow-up. Diuretic therapy was exclusively based on the presence
 and intensity of clinical findings suggestive of pulmonary and/or systemic congestion.
 Clinically oriented patients also underwent a baseline and a final echocardiogram, but the
 decision-making team was unaware of this data throughout the protocol.
Inclusion Criteria:

 1. age greater than 18 years old,

 2. CHF diagnosis for more than 6 months regardless of etiology,

 3. echocardiography-based left ventricular ejection fraction equal or less than 40%, and

 4. prior CHF admission within three months from randomization

 Exclusion Criteria:

 1. thoracic deformity or severe chronic lung disease imposing technical limitation to
 perform high-quality echocardiography,

 2. acute coronary syndrome in the last three months,

 3. congenital heart disease,

 4. moderate to severe stenotic heart valve disease or

 5. end-stage renal failure