Non-aggressive keyhole technique for mitral valve repair has already been used in nearly 200 patients
09.05.2014
Cardiologists at the University Medical Center of Johannes Gutenberg University Mainz (JGU) have performed keyhole procedures for mitral valve repair in almost 200 patients since mid-2010. Thus, the Mainz University Medical Center Mainz is currently among the ten leading centers worldwide with regard to this minimally invasive therapeutic approach. The method is used to correct mitral regurgitation, a condition in which bloods leaks from the mitral valve of the heart. It is particularly non-aggressive and can be used instead of conventional open heart surgery. This innovative method is therefore especially suitable for patients for whom more invasive surgery represents an unacceptable risk because of their advanced age or their medical history.
Mitral insufficiency is a complication that is particularly often encountered in the elderly. In the presence of this serious valvular defect, the workload of the heart is increased and the cardiac muscle can be damaged as a result. A few years ago, surgical intervention was the last resort when mitral insufficiency had become life-threatening and could no longer be managed with the help of medication. However, a conventional surgical operation can represent too great a risk, especially in older patients. It is now possible to treat mitral regurgitation in such high-risk cases using a minimally invasive technique.
"We create an incision of just 0.8 centimeters in the femoral artery and use this to maneuver a catheter into the heart so that we can place a device called a MitraClip at the appropriate location. The procedure, which is performed under general anesthesia, only takes some 60 to 120 minutes," explained Dr. Ralph Stephan von Bardeleben, Deputy Director for Mitral Valve Repair of the Interventional Heart Valve Therapy Unit. "More than 95 percent of patients are responsive shortly after completion of the procedure and can be transferred to a monitoring station." At the Mainz University Medical Center, the technique has proved successful in more than 99 percent of cases, a rate even three percent higher than the European average shown in the Access EU Register, demonstrating the high quality of the cardiac procedures being performed in Mainz.
The Guidelines on the management of valvular heart disease of the European Society of Cardiology issued by the European Society of Cardiology in 2007 show that there is a considerable need for new therapeutic procedures for dealing with mitral regurgitation. This is because in up to 50 percent of cases of symptomatic severe mitral valve insufficiency, treatment is not provided in view of the age of the patient, concomitant disorders, the risk of mortality, or other infirmities. But untreated severe valvular heart defects lead to shortness of breath, deterioration of cardiac function, enlargement of the ventricles, and sometimes to a premature death. "With the help of the new catheter technique, we have managed to significantly extend the already considerable range of surgical options available so that we now also have something to offer to almost inoperable patients," said Professor Thomas Münzel, Director of the Department of Internal Medicine II at the Mainz University Medical Center. "The fact that we are one of the ten leading centers worldwide with regard to these surgical techniques first developed only in 2008 demonstrates how effectively we are living up to our claim that we are continuously acquiring new medical skills," stated Professor Babette Simon, Chairperson and Chief Medical Officer of the Mainz University Medical Center.
The high quality of the procedures performed at the University Medical Center of Johannes Gutenberg University Mainz (JGU) is also confirmed independently in the German Transcatheter Mitral Valve Intervention Register (TRAMI) maintained in Ludwigshafen. This is the largest register of its kind in the world and it currently documents the data for some 1,365 patients. This register is used to record, among other things, the survival rate of high-risk patients who have undergone this procedure. It shows an approximately 96 percent survival rate after 30 days, while the status of patients is to be subsequently monitored by means of telephone contact after 12 months and 5 years. Their physical condition will also be reviewed. The non-center-specific follow-up of nearly 100 percent of the prospective cohort provides new insights into the effectiveness and high level of safety of this therapeutic procedure.
The latest long-term data, presented at the American College of Cardiology (ACC) annual scientific session in Washington in March 2014, demonstrate that the new method is both safe and reliable. Long term outcomes with regard to heart size and cardiac function following use of the MitraClip technique are largely equivalent to those registered after conventional surgery.
The Cedars-Sinai Heart Institute, based in Los Angeles in California, USA, is currently the largest center in America to offer this technique and some 200 patients have undergone treatment in this form there to date. For the USA, this catheter-based procedure was approved by the FDA only in October 2013.