Transcatheter aortic valve replacement (TAVR) likely stepped closer to use in intermediate-risk patients after a multicenter study found patients who underwent transfemoral TAVR with a next-generation valve had a 30-day mortality rate of 2.1 percent.
John Webb, MD, of St. Paul’s Hospital in Vancouver, and other members of the Safety and Performance Study of the Edwards Sapien 3 Transcatheter Heart Valve (SAPIEN3) trial evaluated the safety and efficacy of the Sapien 3 (Edwards Lifesciences) next-generation balloon-expandable transcatheter heart valve in 150 patients with severe aortic stenosis. They published their findings in the Dec. 2 issue of the Journal of the American College of Cardiology.
The new Sapien valve system has a low-crimped profile and an adaptive external seal with delivery catheter systems that are compatible with 14-F and 16-F sheaths for transfemoral procedures and 18-F sheaths for transapical and direct aortic procedures.
All patients in the study received transthoracic echocardiograms at baseline, before hospital discharge and at 30-days. The first 50 patients were high surgical risk while the remaining 100 were intermediate or higher risk, as measured by Society of Thoracic Surgeons (STS) surgical risk score and EuroSCORE.
Webb et al used sizing guidelines for the Sapien XT device that called for routine oversizing but they later developed new CT-based sizing guidelines with a recommended lower range.
Participants’ mean age was 83.6 years, 54 percent were women and the group’s overall STS score and EuroSCORE were 7.4 and 21.6, respectively. More patients underwent transfemoral TAVR (64 percent) than alternative transapical or direct access procedures (36 percent). Patients in the alternative access group were higher risk compared with the transfemoral group.
Webb et al reported one case of malposition and one case of annular rupture. The rate of major vascular complications in the transfemoral group was 4.2 percent with no access-related deaths. They detected severe calcification in 40.6 percent of these patients and tortuosity in 52.2 percent.
“Transfemoral patients had a minimum access arterial diameter of only 6.6 +/- 1.2 mm despite frequent tortuosity and calcification, suggesting that an increasingly broad spectrum of patients will be candidates for a fully percutaneous transfemoral procedure,” they wrote.
The all-cause mortality rate at 30 days totaled 2.1 percent in the transfemoral group and 11.1 percent in the alternative access group. They characterized the mortality rate for transfemoral TAVR with the Sapien 3 valve as “among the lowest ever reported” while the alternative access results were “consistent with a higher risk cohort.”
Stroke rates were 1 percent for transfemoral and 5.6 percent for alternative access procedures. Overall, 13.3 percent of patients needed pacemakers, but they proposed a change in the positioning technique implemented during the trial might reduce the need for pacemakers in the future.
At 30-days, paravalvular regurgitation was absent or trace in 74.3 percent of patients, mild in 22.1 percent and moderate in 3.5 percent. No patients experienced severe paravalvular regurgitation. Overall, heart function, angina class and quality of life measurements improved significantly after TAVR.
“The low rates of mortality, stroke, vascular complications, and paravalvular regurgitation achieved with transfemoral access are among the lowest reported to date and support further evaluation of this new device as an alternative to surgery in intermediate risk patients,” Webb at al wrote.
The study was sponsored by Edwards Lifesciences.