Bernau bei Berlin, 22 November 2021
A high-risk patient with mitral regurgitation was the first to be treated with a new replacement technology at the Immanuel Herzzentrum Brandenburg (Bernau), an MHB university clinic. The team of cardiac specialists used a Tendyne valve in a catheter procedure. The innovative technology is the first treatment option to replace the mitral valve without open-heart surgery in cases where transcatheter valve repair is impossible. Treatment of this patient with pre-existing conditions and a mitral valve that did not close properly was therefore possible without heart-lung machine or open surgery.
The producing company Abbott selected the 63-year-old patient and the heart center via elaborate procedures for the new technology. The Brandenburg clinic with head cardiologist Prof. Dr. Christian Butter was chosen for acknowledged expertise from a large number of applications and is one of the few centers in East Germany where the Tendyne technology is now applied.
The mitral valve is one of four heart valves between cardiac chambers and arteries. It has two cusps or flaps between left atrium and left ventricle. If the flaps do not close properly, blood may flow backward to the atrium with each heartbeat. As a result, a patient suffers from heart insufficiency, and oxygen supply to the organs is insufficient. About two million Germans suffer from heart insufficiency which is among the leading causes of death.
Complex mitral valve as a challenge
The patient had been hospitalized for long periods in other clinics due to his leaking mitral valve; cardiac failure resulted in labored breathing and reduced exercise tolerance. Prof. Dr. Christian Butter, head physician at the cardiology department, Immanuel Klinikum Bernau, says it was a matter of life and death: “Our expert team of heart surgeons, cardiologists and anesthetists decided against open heart-valve surgery as too risky in view of the patient’s pre-existing and general condition. Established catheter-based methods such as a MitraClip were no option either, due to anatomical reasons. What the patient needed was a new heart valve, minimally invasive beating-heart surgery, without heart-lung machine, only via catheter.”
A true challenge. Transcatheter-aortic valve implantation (TAVI) has become a well-established method over the past two decades and since 2008 was practiced as insertion through the groin about 3,700 times at the center in Bernau. But implantation of a new mitral valve via catheterization (TMVI) is more complicated. The anatomy of the valve is more complex, it is highly flexible and located between two left ventricles. Muscle movement and blood flow make it difficult to fix the new valve in place.
According to Prof. Dr. Butter, various approaches have been tried with selected patients, but TAVI turned out to be the most convincing method. Approved in 2020, the Tendyne technology uses an innovative mechanism (a valve tether) to fix the position of the valve.
New technology as the only chance
The innovative technology was the only chance for the patient in Bernau, and the new valve worked right away. After one day in intensive care the Intermediate Care Station took over. The patient has now been discharged from hospital. Prof. Butter confirms that all checkups show a perfectly working mitral valve. As a newly introduced therapy, the new technology will initially be employed with selected patients only.