Contemporary management of severe mitral valve regurgitation involves one of two surgical approaches: open chest surgery or mini-thoracotomy. While both techniques promote effective symptom management, these standard surgical approaches require cardiopulmonary bypass, an intervention reserved for patients with low-to-moderate surgical risk.
In an attempt to broaden treatment offerings for high-risk patients, Sentara physicians are on the front lines of exploring new therapies for severe mitral valve regurgitation — treatments that could offer better outcomes.
APOLLO study examines TMVR for mitral valve regurgitation
An extensive body of research proves the feasibility and effectiveness of transcatheter aortic valve replacement (TAVR) as a primary intervention for severe, symptomatic aortic stenosis. But, there is a distinct lack of evidence pointing to the efficacy of a transcatheter approach for mitral valve replacement. In a first-of-its-kind clinical trial, called the APOLLO study, researchers at Sentara Cardiovascular Research Institute are examining outcomes following transcatheter mitral valve replacement (TMVR) with Medtronic’s Intrepid™device.
Sentara was selected as a study site because of its commitment to high-quality patient care and staff excellence. Sentara demonstrates this through superior patient outcomes and a research team capable of handling the complexity of a study like APOLLO. Plus, our clinical healthcare providers, patient coordinators and ancillary staff possess an in-depth understanding of the patient population included in the study and the disease process itself.
TMVR: A New Concept in Surgery
The APOLLO study represents a new surgical concept in the United States. Mitral valve regurgitation affects significant numbers of older people. Traditionally, they are treated using an on-pump, conventional surgical mitral valve replacement (SMVR) to remove and replace defective mitral valves. In contrast, the APOLLO study features a minimally invasive transapical approach. The procedure is performed off-pump under general anesthesia.
During the procedure, Sentara surgeons access the apex of a patient’s heart through the sixth intercostal space. A small catheter is then threaded through the apex and up through the chordae tendineae to reach the mitral valve. The Intrepid™ device is then deployed through the catheter, taking over mitral valve function and correcting mitral regurgitation.
Study Evaluates Intrepid™ Device for Mitral Valve Regurgitation
Sentara Cardiovascular Research Institute’s efforts are part of a global multi-center study involving randomized, prospective patients and the pre-market Intrepid™ device. Each patient enrolled in the trial must have moderate to severe or severe symptomatic mitral regurgitation.
Before a patient is enrolled, Sentara physicians representing multiple disciplines—interventional cardiology, cardiothoracic surgery, anesthesia and others—meet to review each patient’s medical and personal information to determine their eligibility. Following mitral valve replacement surgery and the initial surgery recovery period, patients receive follow-up care at a minimum of every six months for up to five years.
At one-year post-op, study investigators will measure primary outcomes, including:
- All-cause mortality
- All stroke events
- Cardiovascular hospitalization
- Quality of life improvements
- ECG assessments of improved mitral valve regurgitation
- Days alive outside a hospital environment
Secondary outcome measures at hospital discharge or 30 days post-op (whichever is later) include:
- All-cause mortality
- Disabling stroke events
- Prolonged ventilation
- Acute kidney injury
- Deep wound infection
- Major bleeding
Early APOLLO Results Show Improvements After Mitral Valve Replacement
While researchers have not posted any official results from the clinical trial, they are pleased with the enrolled patients’ early outcomes. The research team notes that recovery from mitral valve replacement, regardless of the type of surgical delivery, is not a quick process.
It is not unreasonable to expect as many as six months to pass after surgical intervention before patients report improvements in symptoms. However, patients enrolled in the APOLLO trial at Sentara report an increased quality of life at 30-day outpatient follow-ups.
Researchers Also Investigate Cardioband™ and MitraClip® for Mitral Valve Repair
Sentara physicians are currently investigating the Cardioband™ adjustable annuloplasty band for mitral valve repair. Instead of correcting mitral valve regurgitation via open chest surgery or mini-thoracotomy, Cardioband™ is delivered through a transfemoral approach. The device deploys and fixes along the posterior annulus of the mitral valve, remodeling the annulus itself. If needed, adjustment to the band can be performed on a beating heart to maximize correction of mitral valve regurgitation.
Additionally, Sentara physicians are leading clinical trials exploring the MitraClip® NTR system and MitraClip® XTR system for the correction of mitral valve regurgitation. Surgeons attach a small clip to the mitral valve, allowing it to close more completely. The device is placed using a transcatheter approach. Currently, clinical trials are intended to confirm the safety and performance of MitraClip® in patients with severe mitral valve regurgitation.
For more information about the Sentara Cardiovascular Research Institute clinical trials, or to begin the patient enrollment process, please contact Chelle Zulick at MRZULICK@sentara.com.