TAVR Bioprosthesis Safe, Effective at 1 Year

SAN FRANCISCO, CALIF.—Results from two studies confirm a “redo” bioprosthesis with a TAVR valve-in-valve procedures may represent a reasonable alternative in older adults with increasing comorbidities, according to two presentations here on Tuesday.

The capability of TAVR in older patients who previously had surgical aortic valve replacement has been well documented across single centers studies. Yet, the feasibility has not been reported for multi-center trials. For this reason, Ralf Müller, MD, of HELIOS Heart Center in Germany, and Michael Sabetai, MD, PhD, of St. Thomas Hospital in London, set out to assess the short- and long-term efficacy of the “redo” procedure in older patients across multiple centers in the United Kingdom and Germany.

RE-DO study

Researchers for the prospective, single-arm, non-randomized RE-DO Study aimed to assess the viability of implantation of an 18F TAVR device (CoreValve, Medtronic) in 18 patients with a failing surgical aortic bioprosthesis. Procedural success was achieved in 94% of patients. Patients were followed for 1 year. Mean age was 79.1 years; 67% were male.

At 30 days, the  mortality rate was 11% and the MACCE rate was 39%. There was one incidence of cardiac death and two strokes. The rate for a new pacemaker was 6%; and 87% of patients showed improvements in at least one New York Heart Association class.

At 1 year, overall mortality was 28% and cardiac mortality was 11%. There were no strokes beyond 30 days and no structural deterioration or valve migration of the CoreValve were reported. Sixty-nine percent of patients showed improvements in at least one New York Heart Association class and hemodynamic measures showed steady improvement (see Figure 1).

“Most patients with a failing surgical bioprosthesis were successfully implanted with TAVR prosthesis in this multi-center feasibility study — improvements were sustained through 1 year,” Müller said. “TAVR in this cohort comes with a unique set of benefits and risks that should be taken into consideration.”

Müller also noted several challenges: “Suture ring of small surgical bioprosthesis may cause strong tendency for ventricular movement of the CoreValve prosthesis. Potential coronary occlusion due to displaced surgical bioprosthetic leaflets or calcium after TAVR has been reported in other published series of TAVR prostheses.”

UK Edwards-Sapien user group

Sabetai presented data from the U.K. Edwards-Sapien User Group. The researchers assessed mortality and morbidity of the TAVR valve-in-valve procedure among 31 cases performed in 10 U.K. centers between 2009 and 2011. Mean age was 79.7 years; and 55% were male.

The procedural success rate was 93.5% with an intraoperative mortality rate of 6.5%. “The valve-in-valve concept is safe, feasible and suggested good hemodynamic results,” Sabetai said. “Patients experienced excellent short-term survival rates. However, larger studies with longer follow up are needed.”

After a median follow-up of 218 days, no patients experienced stroke, MI or aortic regurgitation grade >1. Overall survival rate was 100% (see Figure 2).

Sabetai concluded his presentation with this advice: “Know the bioprosthesis well, know what type it is, know the internal diameter, rely on your fluoroscopic markers and know the technique of surgical implantation.”