TAVR for Surgical Valve Failure
What is the safety and effectiveness of self-expanding transcatheter aortic valve replacement (TAVR) in patients with surgical valve failure (SVF)?
The CoreValve U.S. Expanded Use Study was a prospective, nonrandomized study that enrolled 233 patients with symptomatic SVF who were deemed unsuitable for reoperation. Patients were treated with self-expanding TAVR and evaluated for 30-day and 1-year outcomes after the procedure. An independent core laboratory was used to evaluate serial echocardiograms for valve hemodynamics and aortic regurgitation. Survival curves and other clinical outcomes are presented as Kaplan-Meier estimates. The log-rank test was used to assess possible differences between or among subgroups in time-to-event data.
SVF occurred through stenosis (56.4%), regurgitation (22.0%), or a combination (21.6%). A total of 227 patients underwent attempted TAVR and successful TAVR was achieved in 225 (99.1%) patients. Patients were elderly (76.7 ± 10.8 years), had a Society of Thoracic Surgeons Predicted Risk of Mortality score of 9.0 ± 6.7%, and were severely symptomatic (86.8% New York Heart Association functional class III or IV). The all-cause mortality rate was 2.2% at 30 days and 14.6% at 1 year; and major stroke rate was 0.4% at 30 days and 1.8% at 1 year. Moderate aortic regurgitation occurred in 3.5% of patients at 30 days and 7.4% of patients at 1 year, with no severe aortic regurgitation. The rate of new permanent pacemaker implantation was 8.1% at 30 days and 11.0% at 1 year. The mean valve gradient was 17.0 ± 8.8 mm Hg at 30 days and 16.6 ± 8.9 mm Hg at 1 year. Factors significantly associated with higher discharge mean aortic gradients were surgical valve size, stenosis as modality of SVF, and presence of surgical valve prosthesis patient mismatch (all p < 0.001).
The authors concluded that self-expanding TAVR in patients with SVF at increased risk for surgery was associated with a low 1-year mortality, significantly improved aortic valve hemodynamics, and improved quality of life.
This observational study reports that the use of self-expanding TAVR is safe and effective for SVF in patients unsuitable for SAV replacement. Furthermore, self-expanding TAVR resulted in acceptable aortic valve hemodynamics and low rates of moderate residual AR, with no severe regurgitation at 1 or 12 months. TAV in SAV did result in a higher residual gradient, which does not appear to negatively impact on mortality, morbidity, or quality of life in the short-term. While, longer-term follow-up is essential to determine the impact of the higher residual gradient, this therapy may be considered in patients who are at increased surgical risk because of the low overall mortality and stroke rate and the marked increase in quality of life.
Clinical Topics: Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Noninvasive Imaging, Valvular Heart Disease, Aortic Surgery, Cardiac Surgery and VHD, Interventions and Imaging, Interventions and Structural Heart Disease, Echocardiography/Ultrasound
Keywords: Aortic Valve Insufficiency, Aortic Valve Stenosis, Bioprosthesis, Cardiac Surgical Procedures, Constriction, Pathologic, Echocardiography, Heart Valve Diseases, Heart Valve Prosthesis, Hemodynamics, Pacemaker, Artificial, Quality of Life, Reoperation, Stroke, Transcatheter Aortic Valve Replacement
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