Jean Mirossay, an 82-year-old Concord Township resident, experienced a significant improvement in her quality of life after participating in the Apollo clinical trial for mitral regurgitation (MR). The trial utilized the Intrepid valve, a novel transcatheter mitral valve replacement device, to address her condition, which was complicated by mitral annular calcification (MAC). This marks a significant step forward in treating MR patients who are not candidates for traditional surgical interventions.
Addressing Mitral Regurgitation with the Intrepid Valve
Mitral regurgitation, affecting approximately 4 million people in the United States, occurs when the mitral valve fails to close properly, causing blood to flow backward in the heart. Untreated MR can lead to heart failure, a condition associated with high hospitalization rates and a five-year mortality rate of around 50%. Dr. Guilherme Attizzani, a cardiologist and the director of the UH Harrington Institute’s Valve and Structural Heart Disease Center, explained that Mirossay's case was particularly challenging due to the presence of mitral annular calcification, which narrows the mitral valve and increases the risk associated with surgical valve replacement.
The Apollo Trial and MAC
The Apollo trial investigates the safety and efficacy of the Intrepid valve in patients with symptomatic MR. Mirossay's participation in the trial involved the implantation of the Intrepid valve via catheter, avoiding the need for open-heart surgery. According to Dr. Attizzani, the Intrepid valve offers a significant advantage in patients with MAC because it can be deployed without decalcifying the valve. "With this device, we can just push, put a new valve inside without having to decalcify it," he stated. This approach reduces the surgical risk substantially.
Patient Outcomes and Future Implications
Prior to the procedure, Mirossay experienced significant weakness and reduced mobility. Following the Intrepid valve implantation, she reported a remarkable recovery. "The minute they did it, I got my quality of life back, and I never thought I would have it back," Mirossay said. She underwent thorough pre-operative evaluations, including physical exams, blood tests, echocardiograms, and heart catheterization, to ensure her suitability for the trial. The procedure itself was painless and did not involve any incisions.
Dr. Attizzani believes that devices like the Intrepid valve have the potential to replace surgical approaches for MR treatment if they consistently demonstrate excellent results. Currently, the procedure is limited to clinical trial sites like the UH Harrington Institute, the only hospital in Northeast Ohio participating in the Apollo trial. If the FDA approves the device, it could become more widely available.
Trial Details and Next Steps
The Apollo trial is ongoing, and further data is needed to confirm the long-term safety and efficacy of the Intrepid valve. The trial is enrolling patients who are not suitable candidates for traditional mitral valve surgery or edge-to-edge repair. The primary endpoint of the trial is to assess the device's ability to reduce MR and improve patient outcomes. The results of the Apollo trial could potentially change the treatment paradigm for MR, offering a less invasive option for a broader range of patients.
