Heart Valve System for Patients with Aortic Stenosis

San Francisco—A randomized, controlled trial found that patients with symptomatic, severe aortic stenosis who are not candidates for surgery had similar rates of death and stroke and reduced vascular complications at 30 days if they used the SAPIEN XT transcatheter heart valve system compared with the FDA-approved SAPIEN heart valve.

Martin B. Leon, MD, the study’s lead author, presented the data in a late-breaking clinical trial session at the ACC meeting. Edwards Lifesciences, manufacturer of the SAPIEN and SAPIEN XT, sponsored the trial. Compared with the SAPIEN valve, the SAPIEN XT valve has a new delivery system, new mode of delivery, new frame geometry, new frame material, and new leaflet geometry, according to Dr. Leon.

The SAPIEN XT valve is an investigational device. Edwards Lifesciences said in a news release that it would submit the data from this trial to the FDA later this year and also conclude enrollment of a trial including an intermediate risk cohort.

After 30 days, 17.0% of patients receiving the SAPIEN XT valve died, had disabling stroke, or had a repeat hospitalization for symptoms of aortic stenosis and/or complications of the valve compared with 15.3% of patients receiving the SAPIEN valve (P=.60). There was no significant difference in death (3.5% of patients in the SAPIEN XT group vs 5.1% of patients in the SAPIEN group; P=.36), disabling stroke (3.2% vs 3.0%; P=.85), or repeat hospitalization (11.6% vs 10.2%; P=.59).

In addition, 9.6% of patients in the SAPIEN XT group experienced major vascular complications compared with 15.5% of patients in the SAPIEN group (P=.04), while 7.8% and 12.6%, respectively, had disabling or life-threatening bleeding (P=.06). There were significant reductions in perforations (P=.003) and major dissections (P=.03) in the SAPIEN XT group compared with the SAPIEN group.

At 1 year, 33.9% of patients receiving the SAPIEN XT valve died, had disabling stroke, or had a repeat hospitalization for symptoms of aortic stenosis and/or complications of the valve compared with 34.7% of patients receiving the SAPIEN valve (P=.863). There was no significant difference in death (22.5% of patients in the SAPIEN XT group vs 23.7% of patients in the SAPIEN group; P=.706), disabling stroke (4.5% vs 4.6%; P=.926), or repeat hospitalization (17.4% vs 19.0%; P=.691).

The FDA approved the SAPIEN transcatheter heart valve for treating inoperable patients in November 2011 and expanded the indication in October 2012 to include high-risk surgical patients. The approval was based on results from the PARTNER I (Placement of Aortic Transcatheter Valve) trial that found inoperable patients treated with the SAPIEN valve had reduced mortality compared with a group that received standard therapy only. In addition, high-risk patients had similar mortality whether they used the SAPIEN valve or underwent aortic valve replacement surgery. However, Dr. Leon noted that patients treated with the SAPIEN valve experienced complications such as strokes, vascular events, and paravalvular regurgitation.

In this analysis of the PARTNER II trial, the authors randomized 560 patients at 28 sites in the United States in a 1:1 ratio to receive treatment with the SAPIEN XT valve or the SAPIEN valve. Patients were enrolled between April 2011 and February 2012, and the last patient follow-up occurred on March 1, 2013. All patients were followed for at least 1 year.

Patients were eligible in this analysis if they had severe aortic stenosis, had cardiac symptoms (defined as New York Heart Association functional classification ≥II), and were inoperable, which was assessed by a cardiologist and 2 surgeons as having a >50% risk of death or serious irreversible morbidity. Approximately 50% of patients were males and mean age was 84 years.

Patients who received the SAPIEN XT valve had a mean anesthesia time of 197.6 minutes compared with 212.0 minutes for the SAPIEN valve group (P=.02). In addition, 1.1% of patients in the SAPIEN XT valve group had ≥2 valves implanted compared with 3.7% of patients in the SAPIEN valve group (P=.05); patients in the SAPIEN XT valve group had a reduction in aborted procedures (0.7% vs 3.0%; P=.06) and a reduction in the need for intra-aortic balloon pump hemodynamic support during the procedure (0.4% vs 2.2%; P=.06).