Valve-in-valve transcatheter valve replacement using Sapien XT appears to be a valuable alternative to reoperation in patients with failed aortic bioprostheses, according to 1-year results from the PARTNER II registry presented at the annual TCT Scientific Symposium.
Danny Dvir, MD, and colleagues evaluated 197 patients (mean age, 78.5 ± 11 years, 60.4% male) with symptomatic severe stenosis or regurgitation of a surgical aortic tissue valve at high risk for reoperation, defined as estimated surgical mortality or major morbidity of ≥ 50%.
All patients were suitable candidates for a 23-mm or 26-mm SAPIEN XT transcatheter heart valve (Edwards Lifesciences).
The PARTNER II Valve-in-Valve (VIV) registry was conducted in 99 patients at 24 sites between June 2012 and April 2013, and the PARTNER II VIV extended registry involved 100 patients at 34 sites between May 2013 and December 2013.
The overall Society of Thoracic Surgeons risk score was 9.7% at baseline; further, 95.4% of patients had class III/IV heart failure according to the New York Heart Association system, 70.6% had coronary artery disease, 49.7% had atrial fibrillation, and 33% were considered frail.
The age of failed surgical bioprostheses was < 5 years in 8.1% of patients, 5 to 10 years in 32.4% of patients and > than 10 years in 59.5% of patients. Degeneration had been caused by stenosis in 54.2% of patients, regurgitation in 22.4% of patients and mixed causes in 23.4% of patients.
The study’s primary endpoint was 1-year mortality. Additionally, the researchers evaluated all-cause mortality, CV mortality, all forms of stroke and rehospitalization at 30 days and 1 year, as well as functional and quality-of-life outcomes based on NYHA class, 6-minute walk test distance and Kansas City Cardiomyopathy Questionnaire score. Echocardiographic outcomes included left ventricular ejection fraction and left ventricular mass index.
At 30 days, the rates for all-cause mortality and CV mortality were 4.1% and 3.6%, respectively, based on Kaplan Meier estimates; further, the stroke rate was 2.5% and rehospitalization rate 7.3%. At 1 year, all-cause and cardiac mortality rates had increased to 13.4% and 8.9%, respectively; similarly, the stroke rate rose to 3.7% and rehospitalization rate to 11.8%.
NYHA class distributions at 30 days and 1 year were, respectively: Class 4, 1.1% and 2.5%; Class 3, 10.5% and 9.5%; Class 2, 40.9% and 32.9%; and Class 1, 47.5% and 55.1%.
Although improvements in 6-minute walk test were seen at 30 days (P < .0001), this difference did not retain significance at 1 year; improvements in KCCQ score were seen at both time points (P < .0001 and P = .0001, respectively).
LVEF showed a significant increase at 1 year (P = .02) only, whereas left ventricular mass index was significantly reduced at both 30 days (P < .0001) and 1 year (P = .0002).
“Valve-in-valve TAVR using SAPIEN XT is a beneficial therapeutic alternative to reoperation in patients with failed aortic bioprostheses,” Dvir said. – by Jennifer Byrne
Dvir D. Trasnscatheter aortic valve replacement for failed surgical bioprosthesis: 1-year results from the PARTNER II valve-in-valve registry. Presented at: TCT Scientific Symposium; Oct. 11-15, 2015; San Francisco.
Disclosures: Dvir reports consulting for Edwards Lifesciences and Medtronic.