Valve-in-valve TAVR with Medtronic’s CoreValve devices still safe and effective after 5 years
Valve-in-valve transcatheter aortic valve replacement (TAVR) with a self-expandable valve in patients who have already undergone surgical aortic valve replacement (SAVR) is associated with positive clinical and hemodynamic outcomes after 5 years, according to new research published in the American Journal of Cardiology.[1]
“Although bioprosthetic valves offer the advantage of avoiding long-term anticoagulation, they carry a higher risk of reintervention compared with mechanical prostheses,” wrote first author Tanvir K. Bajwa, MD, an interventional cardiologist with Aurora Sinai/Aurora St. Luke's Medical Centers in Milwaukee, and colleagues. “It is expected that the number of patients with bioprosthetic valve degeneration will increase significantly in the coming years, and many may not be a candidate for repeat surgical valve replacement because of age and co-morbidities. Implanting a transcatheter aortic valve within a failed surgical aortic valve (TAV-in-SAV) has emerged as a less invasive and effective therapy.”
To learn more about the long-term safety and effectiveness of TAV-in-SAV, Bajwa et al. explored data from more than 200 patients treated from March 2013 to May 2015. All patients presented with symptomatic severe aortic stenosis and a history of SAVR, but also faced a high risk of operative mortality. The mean age was 76.7 years old, 63.3% were male and the mean Society of Thoracic Surgeons risk score was 9. The average bioprosthetic valve implant duration was 10.2 years.
All patients were treated with a CoreValve TAVR valve from the trial’s sponsor, Medtronic.
Overall, the group reported, the five-year composite outcome of all-cause mortality or major stroke was seen in 47.2% of all patients. That outcome was seen in 54.4% of patients with stenosis-related valve failure, 37.6% of patients with regurgitation-related valve failure and 38% of patients with both types of valve failure. Additional key outcomes after five years included the mean aortic valve gradient (14.1 mm Hg) and the mean effective orifice area (1.57).
Aortic valve reintervention, meanwhile, was seen in 5.9% of patients, including 4% of patients treated with stenosis-related valve failure, 12.6% of patients with regurgitation-related valve failure and 3% of patients with both types.
“TAV-in-SAV with supra-annular, self-expanding TAVR continues to represent a safe and lasting intermediate option for extreme-risk patients who have appropriate sizing of the preexisting failed surgical valve,” the authors wrote. “Clinical and hemodynamic outcomes were stable through five years.”
Diving deeper into the data, the group also noted that severe prosthesis-patient mismatch (PPM) was seen in 34% after five years. In addition, all-cause mortality after five years was significantly higher in patients who experienced PPM in the first 30 days following treatment.
“This finding supports the premise that a limiting factor for the TAV-in-SAV procedure is appropriate sizing of the original SAVR valve with the patient's annulus,” the authors wrote. “Pre-SAVR multi-slice computed tomography (CT) scanning may be used to determine the functional annular dimensions of the patient to allow implantation of a surgical valve with an internal diameter size greater than the CT scan area-derived mean annular diameter of the patient.”
The full study is available here.
Michael has more than 18 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.