Valve-in-Valve Implantation Found Safe, Feasible

SAN FRANCISCO, CALIF.—Valve-in-valve implantation inside a degenerated bioprosthetic valve may be an effective, less invasive alternative to traditional aortic valve replacement surgery, according to two presenters here.

However, further study is needed, particularly in older patient populations.

Global registry data

Danny Dvir, MD, of the Rabin Medical Center, Petah-Tikva, Israel, presented data from the Global Valve-in-Valve registry.

The study involved 195 patients who received valve-in-valve procedures at 38 sites on multiple continents. The analysis included 120 patients receiving the CoreValve (Medtronic) device and 71 patients receiving the Sapien (Edwards Lifesciences) valve. Thirty-day outcomes were reported in 191 patients and 1-year outcomes were reported in 78 patients (see Figure).

Valve-in-Valve FigureOstial coronary obstruction occurred in 3.3% of patients receiving CoreValve and 4.2% of patients receiving Sapien. “Ostial left main obstruction during these procedures is a concern, especially when using several specific bioprosthetic devices,” Dvir said.

All-cause mortality at 30 days was 7.5% with CoreValve and 12.7% with Sapien.

Dvir noted that significantly elevated post-procedural gradients are common after valve-in-valve procedures, particularly in relatively small bioprosthetic devices treated with currently available Sapien valves. Use of the Sapien valve was a predictor of elevated gradients compared with the CoreValve (OR=2.4; CI 1.2-4.9; P=.01).

“The possible impact of elevated gradients on valve durability should be examined over the long-term,” Dvir said.

“The valve-in-valve procedure, although feasible, is technically demanding and should be reserved for highly experienced centers,” Dvir added. “The technique is clinically effective in most patients, with 1-year results comparable with other TAVR cohorts.”

Additional CoreValve data

Felix Woitek, MD, of the University of Leipzig Heart Center, in Leipzig, Germany, also presented valve-in-valve data on the CoreValve system.

There were 27 patients older than 65 years with a failed aortic valve bioprosthesis eligible for the study.

“These valves fail,” Woitek said. “If you look at the age distribution of these patients, you see that the population is old, and in 10 or 15 years, they will be a more complicated patient population.”

Although there were two fatalities in the first 24 hours after the procedure, Woitek said these occurred fairly early in the learning curve. There were an additional two deaths, the last of which occurred beyond 900 days. “With such a long follow-up, we were happy to have only these four losses.”

Other outcomes reported included life-threatening bleeding (7.4%) and major access site complications (11.1%).

“Transfemoral aortic valve implantation into a failed aortic valve bioprosthesis using the Medtronic CoreValve System in older patients with higher risk for conventional redo surgery is safe and feasible,” Woitek said. “Valve-in-valve procedures result in instantaneous hemodynamic and clinical improvement.”

However, “there are still a lack of randomized data for this device thus far,” Woitek added.

Disclosures
  • Drs. Dvir and Woitek report no relevant conflicts of interest.

Comments