First Patient Suggests Real Promise for Revivent™ Heart Failure Treatment System

We last covered BioVentrix and its clever Revivent™ Myocardial Anchoring system last December when it gained CE marking. The company, a pioneer of technologies and procedures for the less-invasive treatment of heart failure (HF), has now announced the successful first-use of its system, via Less Invasive Ventricular Enhancement™ or the LIVE™ procedure in Germany.

Background

The Revivent Myocardial Anchoring System addresses the safety concerns of physicians about subjecting patients to invasive surgical interventions on the heart’s left ventricle. The system is comprised of a series of titanium anchor pairs, each consisting of an internal and an external anchor, which are placed using transmural catheters. Once the desired number of anchor pairs is positioned, a force gauge is used to guide deployment, pulling the lateral LV wall toward the septum to create a fold of tissue that effectively excludes the non-functioning scar created by a previous heart attack. The ventricle is restored to a more optimal, conical shape, which enhances the performance of the remaining myocardium. The Revivent System is deployed using a straightforward, epicardial approach that can be completed in about one hour.

Prior to the Revivent System, reshaping of the left ventricle used an invasive procedure known as Surgical Ventricular Restoration (SVR), which required stopping the beating heart and supporting it with cardiopulmonary bypass, while incisions into the heart muscle were made to remove the scarred, non-functioning LV tissue. The invasive nature of SVR limits the number of patients for whom the procedure may be performed due to the fragile nature of this patient population. In contrast, the LIVE procedure using the Revivent System is performed without the need of cardiopulmonary bypass or making incisions into the heart.

The successful procedure was performed on a 54-year old man suffering from advanced heart failure at the Schön Klinik Vogtareuth in Vogtareuth, Germany. The interdisciplinary team responsible for performing the procedure was led by Prof. Dr. med. Albert Schütz, Chief of Heart Surgery.

Prior to the procedure, magnetic resonance imaging (MRI) of the heart, demonstrated an ejection fraction of only 12% and significant damage, including scar tissue that extended to the septum and the anterior left ventricular wall.

Postoperative evaluation showed an immediate decrease in left ventricular end system volume index (LVESVI), a predictive indicator of survival for heart failure patients, from 289mL/m2 to 98mL/m2, and an increase in ejection fraction to 33%.

Physician comments

“As a result of a heart attack, this patient suffered from heart failure for two years, that despite intervention with coronary angioplasty and medication, continued to worsen and seriously affected his quality of life,” said Prof. Dr. med. Ralph Haberl, Professor of Internal Medicine and Cardiology at the University of Munich, and the patient’s private cardiologist. “The patient was critically ill and had exhausted all other available treatment options.”

“The LIVE procedure should be considered as a promising treatment option in severe heart failure after myocardial infarction,” said Prof. Haberl.

“The Revivent System was successfully placed using the LIVE procedure, which removes the need for cardiopulmonary bypass and, unlike conventional volume-reduction surgery, does not require an incision into the heart,” said  Prof Schütz. “The entire procedure was uncomplicated, the patient was extubated the same day and he continues to do very well.”

Company comments

“We are very pleased with the adoption of the Revivent System and the LIVE procedure by the cardiac surgery team in Germany,” said Kenneth Miller, president and chief executive officer of BioVentrix. “We believe that our technology not only secures optimal clinical outcomes and improves the quality of life for heart failure patients, but also diminishes the risk inherent in the previous gold standard of conventional SVR.

“We continue to further evolve the Revivent technology and are making great progress in the development of Revivent-TC™, a hybrid transcatheter-minimally invasive approach to the LIVE procedure,” continued Miller. “It is designed to replicate the same outstanding clinical results as the Revivent System; however, this approach will remove the need to open the patient’s chest and will allow the procedure to be performed in the interventional catheterization laboratory.”

Source: BioVentrix, Inc.