An analysis of PARTNER 2 data, published in the June edition of the Journal of the American College of Cardiology, suggests transcatheter aortic valve replacement (TAVR) within failed bioprosthetic surgical aortic valves is a viable long-term solution for high-risk individuals, with patients seeing “excellent” functional and quality of life outcomes three years after the procedure.
Valve-in-valve (VIV) TAVR has already seen some success, first author John G. Webb, MD, of St. Paul’s Hospital in Vancouver, Canada, and co-authors wrote in JACC, and we know patients have seen favorable outcomes at the 30-day and one-year marks. But, Webb and colleagues said, few studies have considered the impact of VIV TAVR beyond one year post-procedure.
For their research, the authors looked at 365 patients with symptomatic degeneration of surgical aortic bioprostheses who underwent VIV procedures at 34 clinical sites. All individuals were at a high risk for reoperative surgery at baseline and had been prospectively enrolled in the multicenter PARTNER 2 VIV and continued access registries.
Subjects, who were in their seventies and eighties at the beginning of the study and averaged a Society of Thoracic Surgeons (STS) score of 9.1, were followed for three years for survival, hemodynamic status, functionality and quality of life. At three years, Webb and colleagues said the overall Kaplan-Meier estimate of all-cause mortality in the population was 32.7%. They also found:
- Aortic valve re-replacement was required in 1.9% of patients at 3 years
- Mean transaortic gradient was 16.6 mm Hg at 3 years, down from 17.8 mm Hg at 30 days and 35 mm Hg at baseline
- Moderate to severe aortic regurgitation fell from 45.1% at baseline to 2.5% at 3 years
- Moderate or severe mitral regurgitation decreased from 33.7% at baseline to 8.6% at 3 years
- Moderate or severe tricuspid regurgitation decreased from 29.7% at baseline to 18.8% at 3 years
- Baseline left ventricular ejection fraction increased from 50.7% at baseline to 54.7% at 3 years
- 90.4% of patients were in New York Heart Association functional class III or IV at baseline, compared to 14.1% at 3 years.
“Long-term follow-up data in the PARNER 2 VIV registry demonstrate sustained valve performance, with no change in transvalvular gradients, indexed effective orifice area or total aortic regurgitation between 30 days and 3 years,” Webb and colleagues wrote. “Remarkable early improvements in functional status and quality-of-life indexes were maintained at 2- and 3-year follow-up.”
In a related JACC editorial, Stephan Windecker, MD, of the University of Bern, and co-authors said even longer-term follow-up of this data will be required, because we don’t know if the positive outcomes experienced by Webb et al.’s cohort will be sustained through the years. They said it’s unlikely researchers will initiate a new randomized trial to compare re-do surgery with VIV TAVR; instead, the procedure will probably gradually become the standard of care.
“Addressing barriers to TAVR in degenerated aortic surgical bioprostheses aims at a moving target,” Windecker et al. wrote. “Anticipating an increase in TAVR in lower-risk patients, the future focus may shift from TAV-in-SAV to TAV-in-TAV. Perhaps we should already be thinking about which transcatheter heart valves are most amenable to repeat intervention and how to optimize current designs to facilitate this.”