Prosthetic Perivalvular Leaks Repaired by New Percutaneous Technique

Charanjit S. Rihal, M.D, Paul Sorajja, M.D and Allison K. Cabalka, M.D.

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74-year-old woman.

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64-year-old woman.

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Diagram of arteriovenous rail.

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74-year-old man.

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Perivalvular regurgitation is a long-standing complication of prosthetic valves. Long-term studies suggest that perivalvular leaks occur in 3% to 7% of aortic and mitral prosthetic valves. Although many patients with prosthetic valves are asymptomatic, severe perivalvular regurgitation may result in heart failure, infective endocarditis, or hemolytic anemia. Reoperative mortality in these patients has been reported to be between 6% and 15%; perioperative morbidity is likewise high.

Interventional cardiologists at Mayo Clinic in Minnesota are investigating the feasibility of treating perivalvular leaks with percutaneous techniques that avoid the risks of operation. "Catheter-based technologies provide an innovative approach to this increasingly common clinical problem," says Paul Sorajja, MD, an interventional cardiologist at Mayo Clinic's Rochester campus.

To date, 23 patients have undergone perivalvular repair with a ductal occluder or septal occluder device. The majority involved a prosthetic mitral valve; a small number involved a prosthetic aortic valve, and there were 2 left ventricle-to-right atrial fistulas in patients with prosthetic mitral valves. All patients had developed either heart failure thought to be primarily due to valve regurgitation or transfusion-dependent hemolytic anemia. All patients were deemed to be at high risk for severe morbidity or mortality at reoperation (many have undergone prior attempted operative procedures), and all clearly understood that this was an investigational, off-label use of these devices.

Periaortic defects were imaged with transthoracic echocardiography in addition to fluoroscopy. Vascular plugs were not feasible because of the lack of a retention disk, but small septal occluder devices could be seated without impinging on the prosthetic valve.

Perimitral positioning of these devices is more difficult. "Many of these patients have severe left atrial enlargement and/or severe mitral annular calcification, making transseptal puncture and catheter manipulation challenging," says Charanjit S. Rihal, MD, director of the Cardiac Catheterization Laboratory at Mayo Clinic in Minnesota. Patients had transesophageal echocardiographic imaging done under general anesthesia in addition to fluoroscopic visualization.

Various guide catheters were used to engage mitral valvular defects; nevertheless, some lesions could not be crossed because of poor guidewire support. In patients with difficult-to-engage lesions and native aortic valves, an arteriovenous rail was created. The arteriovenous rail was developed in 1 of 2 ways: antegradely through the septal puncture, through the periprosthetic defect into the left ventricle, advanced across the aortic valve, and exteriorized through the femoral artery; or retrogradely from the left ventricle, across the periprosthetic lesion, through the left atrium, and then snared and exteriorized through the femoral vein. Additionally, in patients with mechanical aortic valves, left ventricular puncture was performed in selected cases, and the arteriovenous rail was created retrogradely to provide a stable catheter position for approach of a perimitral defect.

Although the procedure was a technical success in nearly all patients, 4 patients died during followup: 1 of pneumonia, 2 of progressive heart failure, and 1 suddenly 4 weeks after the procedure. One patient had successful placement of 2 types of closure devices, but the large defect was too close to the prosthetic leaflet; and each device caused leaflet impingement so was removed percutaneously.

In summary, the present experience has demonstrated that current catheter-based technology is a reasonable approach to repair of perivalvular leaks in patients who are at high risk for operative repair. Improvement in New York Heart Association class was notable, and patients with hemolytic anemia had reduced need for transfusion.

"Our experience has demonstrated the importance of a multidisciplinary team of both congenital and adult interventional cardiologists, anesthesiologists, and echocardiographers in these procedures," says Allison K. Cabalka, M.D., a pediatric cardiologist at Mayo Clinic in Minnesota. "It has also demonstrated the need for innovative use of current technology, and the need for the development of specialized devices to expand utilization of this technique." patient selection criteria and assess long-term patient outcomes.