Valve-in-Valve Registry Evaluates TAVR in Failed Bioprosthetic Surgical Valves

July 9, 2014—A study to determine the survival of patients after transcatheter valve-in-valve implantation inside failed surgical bioprosthetic valves was published by Danny Dvir, et al for the Valve-in-Valve International Data (VIVID) Registry in the Journal of the American Medical Association (JAMA; 2014;312:162–170).

According to the VIVID investigators, it is expected that patients will increasingly present with degenerated bioprostheses in the next few years because of a considerable shift toward bioprosthesis implantation rather than mechanical valves. Transcatheter aortic valve-in-valve implantation is a less invasive approach for patients with structural valve deterioration; however, a comprehensive evaluation of survival after the procedure has not yet been performed.

As summarized in JAMA, the study investigators evaluated correlates for survival using a multinational valve-in-valve registry that included 459 patients with degenerated bioprosthetic valves undergoing valve-in-valve implantation between 2007 and May 2013 in 55 centers (mean age, 77.6 [SD, 9.8] years; 56% men; median Society of Thoracic Surgeons mortality prediction score, 9.8% [interquartile range, 7.7%–16%]). Surgical valves were classified as small (≤ 21 mm; 29.7%), intermediate (> 21 and < 25 mm; 39.3%), and large (≥ 25 mm; 31%). Implanted devices included both balloon- and self-expandable valves. The main outcomes measured were survival, stroke, and New York Heart Association functional class.

The investigators advised that modes of bioprosthesis failure were stenosis (n = 181 [39.4%]), regurgitation (n = 139 [30.3%]), and combined (n = 139 [30.3%]). The stenosis group had a higher percentage (37%) of small valves compared to 20.9% in the regurgitation group and 26.6% in the combined group (P  = .005). Within 1 month after valve-in-valve implantation, 35 (7.6%) patients died, eight (1.7%) had major stroke, and 313 (92.6%) of surviving patients had good functional status (New York Heart Association class I/II).

The overall 1-year Kaplan-Meier survival rate was 83.2% (95% confidence interval [CI], 80.8%–84.7%; 62 death events; 228 survivors). Patients in the stenosis group had worse 1-year survival (76.6%; 95% CI, 68.9%–83.1%; 34 deaths; 86 survivors) in comparison with the regurgitation group (91.2%; 95% CI, 85.7%–96.7%; 10 deaths; 76 survivors) and the combined group (83.9%; 95% CI, 76.8%–91%; 18 deaths; 66 survivors) (P  = .01).

Similarly, patients with small valves had worse 1-year survival (74.8% [95% CI, 66.2%–83.4%]; 27 deaths; 57 survivors) versus patients with intermediate-sized valves (81.8%; 95% CI, 75.3%–88.3%; 26 deaths; 92 survivors) and patients with large valves (93.3%; 95% CI, 85.7%–96.7%; 7 deaths; 73 survivors) (P  = .001). Factors associated with mortality within 1 year included having a small surgical bioprosthesis (≤ 21 mm; hazard ratio, 2.04; 95% CI, 1.14–3.67; P = .02) and baseline stenosis (vs regurgitation; hazard ratio, 3.07; 95% CI, 1.33–7.08; P  = .008).

In this registry of patients who underwent transcatheter valve-in-valve implantation for degenerated bioprosthetic aortic valves, overall 1-year survival was 83.2%. Survival was lower among patients with small bioprostheses and those with predominant surgical valve stenosis, concluded the VIVID investigators in JAMA.