Mitral Valve-in-Valve Improves Outcomes in High-Risk Patients

Transcatheter mitral valve-in-valve/valve-in-ring implantation in high-risk patients is clinically effective in most patients with degenerative mitral valves following surgery, according to results from a registry study presented at TCT 2012.

Danny Dvir, MD, of the Washington Hospital Center in Washington, D.C., and the Rabin Medical Center in Israel, led the analysis of patients included in the Global Valve-in-Valve Registry. The study included a total of 91 patients with degenerated mitral valves after a surgical intervention; 82 patients underwent a valve-in-valve procedure and 9 underwent valve-in-ring procedures; 16 of these were combined valve-in-valve/valve-in-ring procedures. Patients had gone a median of 9 years since their last cardiac procedure.

All patients received a Sapien or Sapien-XT valve (Edwards Lifesciences). Seventy-eight patients (85.7%) underwent procedures using transapical access; other access routes included total transatrial septum (9.9%), femoral vein (8.8%), direct left atrium (4.4%), and jugular vein (1.1%).

After 30 days of follow-up, 10 patients died for an all-cause mortality rate of 11.9%; all deaths were cardiovascular in nature. Only one patient (1.1%) suffered a major stroke, though nine (9.9%) had major vascular complications. The median hospital stay length was 7 days. After the procedure, 78.0% of the cohort improved to NYHA Class I/II.  The 12-month survival rate for the cohort was 74.5% (see figure).

TCT 2012 Dvir Image

Good Results for No-Option Patients

Mitral valve area was 1.96 cm2 postprocedure, and the valve maximum and mean gradients were 13.0 mm Hg and 6.4 mm Hg, respectively. Following the procedure, 4.4% of patients experienced significant mitral regurgitation.

“All of these procedures were performed in patients that are very high risk,” Dvir told TCT Daily. “All of them were postsurgical procedures, most of them were no-option patients.”

He noted that the most worrying complications were related to the surgical procedure. A total of 3.3% of cases had device malpositioning problems, and post-implantation valvuloplasty was used in 8.8% of patients; one patient (1.1%) had a second device implanted. Dvir said he believes the procedural issues will likely improve with more experience, “but we need to see data and a more extensive group of patients” in order to be sure. “We can speculate that once the learning curve issues resolve, then early results could improve, which could then affect the late results.”

The mean age of patients in the registry was 75.0 years, and 64.4% were female. Diabetes mellitus was present in 28.9% of the cohort, and 54.9% had chronic renal failure; 26.1% had previous stroke, 55.7% had AF, 33.0% had permanent pacemakers implanted, and 98.9% of the patients were at NYHA class III or IV.

“For these patients to end up with relatively high functional class after the procedures, I think these are very promising results,” Dvir said.

Most valve-in-valve patients had a Carpentier-Edwards Perimount device (61.0%), while some had a Medtronic Hancock II (14.6%), or other device. Most valve-in-ring patients had a Carpentier-Edwards Physio ring (66.7%), a St. Jude Seguin (22.2%), or a Duran ring (11.1%).

Disclosures
  • Dr. Dvir reports no relevant conflicts of interest.

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