Heart separation device improves 3 year outcomes in heart failure patients

August 27, 2012

A novel non-invasive device which separates healthy and damaged heart muscle and restores ventricle function improves 3 year outcomes in patients with ischemic heart failure, according to research presented at the ESC Congress 2012. The findings were presented by Professor William T. Abraham at an ESC press conference on 25 August and by Dr Marco Costa at an ESC Congress scientific session on 27 August.

is a common, debilitating, and potentially deadly condition in which the is unable to supply sufficient blood flow to meet the needs of the body. Symptoms of heart failure negatively impact quality of life and include shortness of breath, persistent coughing or wheezing, buildup of excess fluid in body tissues (edema), fatigue, lack of appetite or nausea, impaired thinking, and increased heart rate. More than 20 million people around the world are affected.

Many heart attack survivors experience enlargement of the heart, causing a decrease in cardiac output that results in heart failure symptoms such as fatigue and shortness of breath. The healthy portion of the heart not affected by the heart attack has to compensate for the loss in output and becomes overloaded over time. Current treatment options for patients whose hearts have enlarged are limited.

The Parachute Ventricular Partitioning Device is the first minimally for caused by damage to the following a heart attack. The Parachute device is implanted in the through a small catheter inserted in the .

"The device creates a barrier between the non-functioning, damaged segment of heart muscle and the healthy, functional segment of heart muscle," said Dr Costa. "This decreases the overall volume of the left ventricle chamber and restores its optimal geometry and function. The procedure is performed in the catheterization laboratory under ."

Two-year clinical data presented at the EuroPCR conference earlier this year demonstrated improved overall cardiac function and quality of life for patients treated with the Parachute device.

The current study included 31patients treated in the US and Europe with the Parachute system. The New York Heart Association (NYHA) Functional Classification of 1 (mildest) to 4 (most severe) was used to define the severity of heart failure at 1, 2 and 3 years after treatment.

The average NYHA class at baseline was 2.6. This improved to 1.6 (p<0.001) at 1 year, 1.9 (p<0.01) at 2 years and 1.8 (p<0.0001) at 3 years post treatment. Dr Costa said: "This shows that the severity of heart failure maintained its improvement over time after treatment with the Parachute device."

The proportion of patients who were hospitalized due to worsening heart failure increased from 29.7% at 2 years to 33.2% at 3 years after treatment. "This small increase could be because the Parachute is specifically targeting the structural heart problem by excluding the scar caused from a heart attack which initiated the negative ventricle remodeling," said Dr Costa.

The low cardiac death rate of 6.5% at 2 years remained unchanged at 3 years. "This suggests that percutaneous ventricle restoration with the Parachute system results in a plateau of the progression of heart failure in these patients," said Dr Costa. "These outcomes compare favorably with current medical therapy in a similar high-risk patient population."

"These results are compelling," said Professor Abraham. "The sustained improvements in functional capacity and plateauing effect seen in outcomes three years after treatment with the Parachute device are particularly encouraging, showing that we may be able to slow the progression of heart failure – a very exciting prospect."

"We were already very excited about the two-year clinical data presented at the EuroPCR conference earlier this year," said Dr Costa. "Our three-year results in this high-risk population reinforce our initial enthusiasm and fuel our motivation to start a large randomized trial later this year."

Dr Costa concluded: "In these two first-in-man studies we have shown that the Parachute device is safe and leads to sustained improvements in symptoms, heart function, and clinical outcomes over three years. This points to a potentially historical turning point in the treatment of heart failure caused by a ."

Explore further: UH Case Medical Center, CardioKinetix reveal promising data for treatment for heart failure

Related Stories

UH Case Medical Center, CardioKinetix reveal promising data for treatment for heart failure

May 18, 2012
University Hospitals (UH) Case Medical Center and CardioKinetix Inc., a medical device company pioneering a catheter-based treatment for heart failure, today announced promising results for the first-of-its-kind catheter-based ...

Heart failure's effects in cells can be reversed with a rest

April 2, 2012
Structural changes in heart muscle cells after heart failure can be reversed by allowing the heart to rest, according to research at Imperial College London. Findings from a study in rats published today in the European Journal ...

Renal denervation gives better outcomes than drugs in advanced heart failure

August 27, 2012
Renal denervation leads to better outcomes than standard drug treatment in patients with advanced heart failure, according to research presented at ESC Congress 2012. The results of the Olomouc I pilot study were presented ...

HFSA updates recommendations for use of cardiac resynchronization therapy

February 27, 2012
Based on a review of the latest evidence, the Guidelines Committee of the Heart Failure Society of America now recommends that the use of cardiac resynchronization therapy (CRT) be expanded to a larger group of patients with ...

Recommended for you

Scientists rewrite our understanding of how arteries mend

December 13, 2017
Scientists from The University of Manchester have discovered how the severity of trauma to arterial blood vessels governs how the body repairs itself.

Ultra-thin tissue samples could help to understand and treat heart disease

December 12, 2017
A new method for preparing ultra-thin slices of heart tissue in the lab could help scientists to study how cells behave inside a beating heart.

Research reveals how diabetes in pregnancy affects baby's heart

December 12, 2017
Researchers at the Eli and Edythe Broad Center of Regenerative Medicine and Stem Cell Research at UCLA have discovered how high glucose levels—whether caused by diabetes or other factors—keep heart cells from maturing ...

Young diabetics could have seven times higher risk for sudden cardiac death

December 12, 2017
Young diabetics could have seven times more risk of dying from sudden cardiac arrest than their peers who don't have diabetes, according to new research.

Blood flow–sensing protein protects against atherosclerosis in mice

December 12, 2017
UCLA scientists have found that a protein known as NOTCH1 helps ward off inflammation in the walls of blood vessels, preventing atherosclerosis—the narrowing and hardening of arteries that can cause heart attacks and strokes. ...

Half of people aged 40-54 have hardened arteries: study

December 11, 2017
Half of middle-aged people who are normal weight and don't smoke or have diabetes may have clogged arteries, researchers said Thursday, urging stronger measures to lower cholesterol.

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.