An Alternative for Traditional Surgical Mitral Valve Replacement?
December 31, 2017
UH participating in important trial of novel transcatheter mitral valve replacement device?
Harrington Heart & Vascular Institute Innovations - Winter 2018
A less invasive option for treating mitral insufficiency is under investigation in a clinical trial at University Hospitals Harrington Heart & Vascular Institute. As part of the APOLLO trial, UH patients with severe symptomatic mitral regurgitation will have the opportunity to be randomized to receive either conventional open-heart mitral valve replacement surgery or an investigational transcatheter mitral valve replacement (TMVR, Intrepid) procedure. In addition, patients who are not good surgical candidates could have the opportunity of being treated with TMVR
According to UH interventional cardiologist Guilherme F. Attizzani, MD, Co-Director, Valve and Structural Heart Disease Center, University Hospitals Harrington Heart & Vascular Institute, Co-Director, Cardiovascular Imaging Core Laboratory, University Hospitals Cleveland Medical Center; John C. Haugh Valve Fellow and Assistant Professor of Medicine, Case Western Reserve University School of Medicine, the APOLLO trial is a welcome development for patients with mitral valve disease.
“There is currently no TMVR technology approved by the FDA and this trial may open a new, very important avenue on the field,” he says. “The only percutaneous technologies we currently have to treat mitral insufficiency are MitraClip, which enables percutaneous native mitral valve repair, and transcatheter valves used for valve-in-valve procedures (i.e., treatment of a failed surgical valve). This study is, therefore, extremely important as it may lead to a paradigm shift in terms of the treatment of native mitral valve insufficiency.“
The APOLLO trial is testing the Intrepid transcatheter mitral valve replacement system, which is compressed inside a hollow delivery catheter and is inserted between the ribs to enter the heart. The new replacement valve is expanded directly into the malfunctioning mitral valve. The outer stent frame is designed to attach and conform to the native valve without the need for additional sutures, tethers, or anchors to secure the prosthesis. The inner stent houses the valve, which is made from bovine tissue and is intended to maintain blood flow.
The Intrepid valve is implanted using a transapical approach. However, according to Alan Markowitz, MD, Chief Surgical Officer, and Director, Valve and Structural Heart Disease Center, University Hospitals Harrington Heart & Vascular Institute, Marcella “Dolly” Haugh Chair in Valvular Surgery; Clinical Assistant Professor of Surgery, Case Western Reserve University School of Medicine, this technology is expected to evolve and become even less invasive.
“Today, surgeons need to open a small hole in the apex of the heart, then the valve is advanced through it and implanted. It’s a beating-heart procedure without the heart-lung machine. Industry is, however, already working on a technology that is going to be transseptal (i.e., can be done via puncture of the femoral vein). This will further reduce the invasion to the patient by not having to go through the apex.“
UH is the only health care system in Northeast Ohio to give its patients access to the APOLLO trial. For Dr. Markowitz, it’s all part of providing comprehensive care to patients with mitral valve disorders.
“In addition to the APOLLO trial, we also offer MitraClip therapy, an FDA-approved therapy for mitral valve insufficiency,” he says. “We also perform valve-in-valve and other complex procedures. It’s the full spectrum of mitral valve interventions, a combined effort of interventional cardiology and cardiac surgery.”
Two recent hybrid mitral interventions performed at UH illustrate the point. Dr. Attizzani and UH cardiac surgeon Benjamin Medalion, MD, performed a double valve procedure on an 89-year-old woman who had a failing bioprosthetic valve in the mitral position and who also needed a new aortic valve. Dr. Medalion did an open procedure first to make some modifications to the mitral valve and then he and Dr. Attizzani placed a transcatheter valve inside the degenerated mitral bioprosthesis. The case was completed with an open surgical aortic valve replacement performed by Dr. Medalion. In a second case, Dr. Attizzani and UH cardiac surgeon Basar Sareyyupoglu, MD, collaborated on another hybrid procedure to place a transcatheter valve in mitral position inside a degenerated bioprosthesis via the left atrium. This case was complicated by the fact that the 76-year-old patient had a large left atrial clot, which was surgically removed before the new valve was successfully implanted.
“These cases were extremely challenging but very successful.” Dr. Attizzani says. “The patients are doing well.”
Once the APOLLO trial is completed, Dr. Attizzani says he expects patients with mitral valve disease to have even more great options to treat mitral valve disorders.
“Although it is impossible to predict the trial results, my expectation is that the TMVR system will be shown to be safe and effective,” he says. “If it is demonstrated to be non-inferior to surgical mitral valve replacement, it will be a key step in terms of the potential future approval of this novel technology by the FDA, ultimately enabling more patients to have the option of an effective and less invasive procedure.”
For more information on the APOLLO trial under way at UH, please call 216-844-6138.