PERCUTANEOUS TRANSLUMINAL CAVAL FLOW
RESTRICTION (PTCR) IN A PATIENT WITH CONGESTIVE HEART FAILURE
A new procedure and a hope, for the congestive heart failure treatment.
INTRODUCTION
Congestive
heart failure (CHF) constitutes the most serious public health problem in the
United States of America, representing high costs, with a prevalence of
12.5-13% in the population of 65 years or older (1). So far,
preload reduction in patients with Congestive Heart Failure (CHF) is performed
by the use of high potency diuretics. We have previously reported that a
Dynamic Stenosis of the Inferior Vena Cava (IVC) associated with beneficial
hemodynamic changes occurs, in some patients with CHF(2,3). Here, we are
reporting the first case of intermittent preload reduction by the use of an
inflated balloon placed in the high IVC and guided by respiratory phases
resulting in total occlusion during inspiration and subtotal occlusion during
expiration.
IVC DYNAMIC STENOSIS (Clinical Entity)
IVC dynamic
stenosis (IVCDS) (Fig.1) is an entity recently discovered by our group (2,3)
with a prevalence of 0,5%. IVCDS intermittently decreases venous return,
depending on the respiratory phase, specifically during inspiration when the
IVC diameter is reduced by 20-30% due to inspiratory collapse, and a fibrotic
formation in the right cava-diaphragmatic junction (Fig.1) regularly occupies
70-80% of the IVC diameter. Producing total occlusion during inspiration and
sub-total occlusion during expiration.
HYPOTHESIS
Intermittent
IVC flow restriction produces beneficial hemodynamic changes in CHF patients.
DYNAMIC STENOSIS MODEL
How it Works
U.S. Patented Catheter Balloon Restrictor #8868869.
IVC DYNAMIC STENOSIS ARTIFICIAL MODEL U.S. Patented Method #8868869.
FIRST CASE REPORT
A 66 years
old Female heavy smoker patient with history of a heart attack whe she was 46
years old, and hopitalization for acute congestive heart failure in October
2013. Actualy recieving optimal medical treatment (Carvedilol, Furosemide,
Enalapril, and Aldosteron receptor bloquersand nitrates sl). Now in funtional
class NYHA IIb/3, angina type 3 and was diagnosticated as ischemic heart
desease, congestive heart failure,
severe left ventricular (LV) dysfunction (EF 39%), and severe diastolic
dysfunction with high LV filling pressure, laboratory was Urea: , Creatinine: ,
Pro_Bnp: , scheduled for coronary
angiogram. The patient was screened and enrolled in our caval flow protocol
trial. Coronary angiography revealed severe coronary artery desease, triple
vessel desease and left main 50%.
METHOD AND PROCEDURE
Basal
Doppler echocardiogram measurements were performed previous coronary artery
angiography. After coronary angiography a 6 Fr sheath was inserted in the right
cephalic vein, to evaluate right side pressures before and after IVC Balloon
restriction, then we introduced the catheter balloon for venous occlusion via femoral
vein and was advanced just before Hepatic Vein drainage (echo guided), then the
balloon was inflated up to 10mm according to the previous calculations to reach
the IVC dynamic restriction. A turbulent flow was observed and the IVC velocity
was measured at 2 cm from the right atrium and caval flow velocity was 1.08
m/s, and then was inflated up to 13 to 14 mm achieving caval flow velocity up
to 1.28 m/sec. The balloon remained inflated for 25 minutes. Echocardiogram
measures were performed during IVC dynamic restriction. Then the balloon was
deflated, and retired from the patient. During the procedure, the patient heart
rates and blood pressures were monitorized.
PTCR PROCEDURE
RESULTS
Right heart
pressures and echocardiographic measurements showed: 44% reduction in pulmonary
capillary pressure, 38% right ventricular pressure, and 60% reduction of the
right atrium pressure compared with baseline. The LV diastolic diameter was
reduced by 8% and systolic diameter decreased 18%, Ee' was reduced by 20%
indicating reduction of LV filling pressure, the LVEF by Teicholz increased
from 39% up to 45% (15%), by Simpson decreased from 45% to 40% by reducing
8.8%, cardiac output decreased from 2.61 l/min to 2.31 l/min during balloon
inflation.
GRAPHIC RESUTS
CONCLUSION
We are
reporting the first experience in humans of a new procedure for intermittent
preload reduction in patients with CHF. The beneficial hemodynamic and
echocardiographic changes obtained in this patient suggest that this new
procedure may play role in the treatment of patients with CHF. Large studies
are needed to further evaluate this new procedure.
REFERENCES
1. Heart Desease and Stroke, Statistics. 2007,
update a report
from the American Heart Association
Statistic committee
and stroke statistics sub. Committee.
2. José Herrera C,
José A. Herrera P, Juan Marques, Iván Mendoza.
Novel Method to Reduce Preload
Mechanically in Patients with
Congestive Heart Failure, The Dynamic
Restriction of Flow in the
inferior Vena Cava. Europeean Congress of
Congestive Heart
Failure. 2011. Abstrat.
Gothenburg, Suecia. Abstract.
3. Jose Herrera C,
Jose A. Herrera P, Juan Marques,Ivan Mendoza.
Congestive Heart Failure Patients
and Dynamic Stenosis of Cava,
Associated, Comparisson with a healthy
population.
Europeean Congress of Congestive Heart
Failure 2013, Lisbon
Portugal, Abstrat.
PATENTS OBTEINED
- USA. USPTO # 8868869. Method and device for the regulation of venous return in patients with heart failure.
PATENTS PENDING
- PCT Switzerland. Pat Pending. Method and device for the regulation of venous return in patients with heart isuficiencia.
- Chapter 2 Europa National Phase, Application #. Method and device for the regulation of venous return in patients with heart isuficiencia.
- Chapter 2 National Phase Russia. Request #. Method and device for the regulation of venous return in patients with heart isuficiencia.
RESEARCH PROTOCOL - IN PROGRESS
Acute hemodynamic changes, after Percutaneous Transluminal Caval flow Restriction, in patients with ischemiq and non ischemiq congestive heart failure. Now five patients enrolled.
RESEARCH PROTOCOL. (Waiting for Grant)
Evaluation of the safety and efficacy of the IVC balloon device in Congestive Heart Failure in animal models, MGH Boston USA.
PRESENTATIONS PERFORMED
- Irregular
Motility Inferior Vena Cava in Patients with Atrial Fibrillation. National
Congress of Cardiology. Maracaibo - Venezuela. Award for best
research.
- Motility
of the inferior vena cava in Normal patients. Venezuelan Congress of
Cardiology - Nueva Esparta - Venezuela.
- Mechanical
Regulation of pre-load in patients with heart failure. Venezuelan Congress
of Cardiology. Caracas - Venezuela. Award for best research.
- Mechanical
Regulation of Pre-load in Patients with Heart Failure. American Congress
of Echo-Cardiography. Chile. Award for best research.
- Mechanical
Regulation of Pre-load in Patients with Heart Failure Compared with CHF
Patients without mechanical adjustment of Pre-load. European Congress of Heart
Failure, Guthemberg - Sweden, 2011.
- Conference,
IVC Project. National Academy of Medicine. 2012.
- Comparison
of Patients with Mechanical Adjustment of Pre-load and ICC with normal
subjects. European
Heart Failure Congress, Lisbon 2013.
- Conference,
What Hides the Inferior Cava. Venezuelan Congress of Preventive
Cardiology. Caracas
- Venezuela, 2013.
- Conference,
The inferior vena heart failure. Inter American Congress Eco-cardiography
(ECOSIAC). Porlamar - Venezuela. 2013
- Inferior
Vena Cava in Vasovagal Syncope, a New Guest Star. Venezuelan Congress of
Cardiology. Caracas - Venezuela. 2014.
- Conference,
How to Explore the Inferior Vena Cava. Venezuelan Congress of Cardiology. Caracas -
Venezuela. 2014.
PRESENTATIONS TO BE PERFORMED
- First
PTCR in Congestive Heart Failure Patient - Poster. Washigton TCT 2014 Conference
USA.
- First
PTCR in Congestive Heart Failure Patient - Oral Presentation. Washigton TCT 2014 Conference
USA.
Innovation Award granted to Dr. Herrera, for his outstanding Innovation Idea.
Dr. Herrera obtained the 2nd place in the Runner Up category.
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