Reshaping the future of the Treatment of Congestive Herat Failure.

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.