Percutaneous transvenous transseptal transcatheter valve implantation is safe and effective in patients with degenerated bioprostheses, according to data recently published in JACC: Cardiovascular Interventions.
The procedure was also associated with rapid improvement in hemodynamics, short hospital stay, and improved functional status.
Although transcatheter valve implantation is a promising therapy for patients with degenerated mitral bioprostheses, the procedure poses many challenges, including a lack of direct visualization during deployment and the lack of direct fixation of the valve when using sutures.
Therefore, researchers of the study sought to determine the feasibility, safety, and intermediate-term outcomes of percutaneous antegrade transvenous transseptal mitral valve implantation in patients with failed bioprostheses, ring annuloplasty, and calcific mitral stenosis.
“We have developed techniques to minimize complication rates, thus increasing the safety of the procedure,” the authors wrote. “The high success rate in patients with bioprostheses was demonstrated in a wide variety of prosthesis types, sizes and in mode of failure, demonstrating the versatility of the SAPIEN valve system.”
The percutaneous transfemoral antegrade transseptal implantation with the SAPIEN prosthesis (Edwards Lifesciences; Irvine, CA) was performed in 48 patients with either degenerated mitral bioprostheses (n=33), previous ring annuloplasty (n=9), or severe calcific mitral stenosis (n=6). The mean Society of Thoracic Surgery (STS) risk score in the total cohort was 13.2% ± 7.4% and the mean age was 76 ± 11 years.
Acute procedural success was achieved in 42 out of 48 patients (88%) overall, in 31 out of 33 patients (94%) in the failed bioprosthetic mitral valve group, and in 11 out of 15 patients (73%) with failed annuloplasty rings and mitral annular calcification.
No patients had greater than mild residual mitral prosthetic or periprosthetic regurgitation after a successful procedure, and mean transvalvular gradients were 6 ± 2.5 mmHg. The 30-day survival rate— free of death and cardiovascular surgery—was 85% in the total cohort and 91% in the failed bioprosthetic mitral valve subgroup.
Although there was a high success rate among patients with failed mitral bioprostheses, the authors noted that further investigation is necessary for patients with failed rings and annular calcification.
“Larger scale studies and data on long term outcomes of patients undergoing percutaneous mitral valve-in-valve implantation are needed, as well as the development of dedicated devices for transseptal mitral valve implantation,” the authors concluded.
Eleid MF, Cabalka AK, Williams MR, et al. Percutaneous transvenous transseptal transcatheter valve implantation in failed bioprosthetic mitral valves, ring annuloplasty, and severe mitral annular calcification. JACC Cardiovasc Interv. 2016. doi:10.1016/j.jcin.2016.02.041.