A novel non-invasive device which separates healthy and damaged heart muscle and restores ventricle function improves three-year outcomes in patients with ischaemic heart failure, according to research presented at the ESC Congress 2012 in Munich, Germany. The findings were presented by William T Abraham at an ESC press conference on 25 August and by Marco Costa at an ESC Congress scientific session on 27 August.
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 invasive treatment for patients with heart failure caused by damage to the heart muscle following a heart attack. The Parachute device is implanted in the left ventricle through a small catheter inserted in the femoral artery.
“The device creates a barrier between the non-functioning, damaged segment of heart muscle and the healthy, functional segment of heart muscle,” said Costa. “This decreases the overall volume of the left ventricle chamber and restores its optimal geometry and function. The procedure is performed in the catheterisation laboratory under conscious sedation.”
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 31 patients 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 one, two and three years after treatment.
The average NYHA class at baseline was 2.6. This improved to 1.6 (p<0.001) at one year, 1.9 (p<0.01) at two years and 1.8 (p<0.0001) at three years post treatment. 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 hospitalised due to worsening heart failure increased from 29.7% at two years to 33.2% at three 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 Costa.
The low cardiac death rate of 6.5% at two years remained unchanged at three 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 Costa. “These outcomes compare favourably with current medical therapy in a similar high-risk patient population.”
“These results are compelling,” said 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 Costa. “Our three-year results in this high-risk population reinforce our initial enthusiasm and fuel our motivation to start a large randomised trial later this year.”
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 heart attack.”