Introduction Heart failure (HF) affects 6.2 million patients in the United States and was
responsible of 13.4% of deaths in 2018 costing about 30.7 billion USD in 2012, and about
80% of all the patients with HF are >65 years old. Clinical manifestations include
shortness of breath and peripheral edema. Diuretics are indicated to treat edema in
patients with HF, however, its use is limited in patients with compromised kidney
function. Peripheral edema is associated with pain, heavy legs, limited mobility, and
poor quality of life, increasing the risk of cellulitis, and wounds. Heart failure was
identified in up to 44% of patients with venous ulcers. The chronic use of compression
stockings in HF patients has potential benefits such as a better control of the edema,
decreasing the need for diuretics, improving mobility, prevention of progression of
venous disease, and prevention of venous ulcers. To date, no major HF guidelines
recommend in favor or against compression stockings in HF patients.
Previous studies in patients with HF who had a pulmonary artery catheter in place, showed
that compression of the lower extremities increases the right atrial pressure. However,
it was a short intervention, and there was no evidence of clinical deterioration or
worsening symptoms of HF. A retrospective review from a wound center showed that the use
of compression therapy in HF patient was not associated with an increase in death,
hospitalizations, or use of diuretics.
Hypothesis: The hypothesis is the use of compression stockings would prevent developing
or worsening venous disease (venous reflux, and venous ulcers), improving the edema of
the lower extremities, mobility and quality of life in HF patients without increasing the
risk of HF deterioration, hospitalization, or death. To obtain preliminary information,
this study proposes to randomize 30 patients with HF (New York Heart Association class
II-III, stage A, B or C) on maximum medical therapy to 3 months of compression stockings
20-30 mmHg knee high (High compression group, n=15) vs. regular stocking with ≤10 mmHg of
compression (Low compression group, n=15).
Aim 1. To determine whether the use of graduated 20-30 mmHg compression stockings are
associated with clinical deterioration or increase is hospitalization or death in
patients with HF. Patients will be evaluated at baseline, in a week after enrollment
(telemedicine), and at three months. The New York Heart Association (NYHA) clinical
classification, the Kansas City Cardiomyopathy Questionnaire (KCCQ), levels of brain
natriuretic peptide, serum creatinine, documentation of diuretic therapy, body weight,
visits to the Emergency Department, hospitalizations and deaths will be obtained on the
baseline and 3-month visit. The change in NYHA clinical classification, KCCQ, body
weight, diuretic dosage and any adverse events will be compared at 3 months.
AIM 2a. To evaluate if the use of graduated 20-30 mmHg compression stockings is
associated with prevention of developing or worsening venous reflux. The presence of
venous reflux will be documented with a venous duplex of the lower extremities looking
for reflux and obstruction. The difference in time (3-month - baseline) of venous valve
closure in milliseconds in bilateral common iliac, common femoral, femoral, popliteal
veins, saphenous-femoral junction, great saphenous and small saphenous veins will be
documented and compared between high compression and low compression stocking groups.
AIM 2b. To evaluate if the use of graduated 20-30 mmHg compression stockings is
associated with prevention of developing or worsening clinical signs of venous
insufficiency (C class of CEAP C1-C6). A brief physical exam of the lower extremities
will be performed to obtain the C class for the CEAP classification for venous disease at
baseline and 3 months. The C score will be compared between high compression and low
compression stocking groups.
Aim 3. To evaluate if the use of graduated 20-30 mmHg compression stockings is associated
with improvement of mobility and quality of life in heart failure patients. The quality
of life will be documented using the VEINS QoL and SF-36 questionnaires; and the mobility
will be assessed using the Short Physical Performance Battery test (SPPB). Patients will
be evaluated at baseline and at 3-months visits. The difference in scores (3-month -
baseline) will be compared between high compression and low compression stocking groups.