Valve-in-Valve TAVR Benefits Patients with Failing Surgical Bioprosthetic Valves
Valve-in-valve transcatheter aortic valve replacement (TAVR) with a balloon-expandable system was associated with positive outcomes in high-risk patients who have failing surgical bioprostheses, according to results presented in the Main Arena at TCT 2015.
Researcher Danny Dvir, MD, of St. Paul’s Hospital, Vancouver, Canada, also announced that the FDA has approved Sapien XT (Edwards Lifesciences) for the valve-in-valve TAVR indication.
Death, stroke rates low
Among 197 patients enrolled in the PARTNER II Valve-in-Valve Registry and the Valve-in-Valve Extended Registry, all-cause mortality was low at 30 days (4.1%) and 1 year (primary endpoint; 13.4%). Mortality at 1 year was similar for transfemoral and transapical procedures (13.2% and 14.0%, respectively; P = .83). There also were low rates of other clinical outcomes at 1 year, including cardiac mortality (8.9%), stroke (3.7%) and rehospitalization (11.8%).
The most common procedural complication was major bleeding (14.8%), followed by acute kidney injury (8.2%). Coronary obstruction occurred in only one patient (0.5%), and three patients each (1.5%) required a second transcatheter valve or a new pacemaker implant.
At baseline, 95.5% of patients had NYHA class III or IV symptoms. That proportion declined to 11.6% at 30 days (P < .0001), and that improvement was maintained at 1 year (12%).
From baseline to 30 days, patients improved in 6-minute walk distance, mean gradient and aortic valve area (P < .0001 for all). LV ejection fraction increased from 30 days to 1 year (P = .02), and LV mass index declined steadily from baseline to 1 year. Quality of life, measured with the Kansas City Cardiomyopathy Questionnaire, showed gains throughout the first year of follow-up.
Severe aortic regurgitation (AR) declined from 16.3% at baseline to 0.6% at 30 days, with no severe cases remaining at 1 year. Moderate AR fell from 27.3% at baseline to 1.8% at 30 days (P < .0001), with that low level maintained out to 1 year (1.9%). Moderate/severe mitral and tricuspid regurgitation both declined in the first 30 days after the procedure, with no further changes from 30 days to 1 year.
All-cause mortality was higher at 1 year in those who had a 21-mm surgical valve vs. those with larger valves (20.4% vs. 11.1%; P = .09) and among patients with a mean gradient ≥ 20 mm Hg at discharge vs. those with smaller gradients (17.3% vs. 8.3%; P = .09). Quality of life increased to a similar extent through 1 year regardless of valve size or gradient at discharge.
Good outcomes in high-risk patients
All patients (60.4% men; mean STS score 9.7; 33% frail) had symptomatic severe stenosis or regurgitation of a surgical aortic tissue valve, were considered high risk for reoperation (estimated risk of surgical mortality or major morbidity ≥ 50%) and were deemed suitable for a 23-mm or 26-mm Sapien XT valve, Dvir said.
“This was a very high-risk group of patients,” he concluded. “We have seen excellent freedom from mortality, and stroke and major adverse events were low. There was a significant clinical benefit in terms of symptoms, in terms of functional status, in 6-minute walk test and in quality of life. Valve-in-valve TAVR using Sapien XT is a beneficial therapeutic alternative to reoperation in patients with failed aortic bioprostheses.”
- Dvir reports consulting for Edwards Lifesciences and Medtronic.