A new generation balloon-expandable transcatheter heart valve (THV; SAPIEN 3, Edwards Lifesciences; Irvine, CA) designed to minimize paravalvular leakage was associated with a high rate of device success and a low rate of clinical events at 30 days.
“In addition to these promising clinical results, we observed an increased rate of new permanent pacemaker implantations,” the researchers wrote.
With 30-day outcome data on the THV limited, researchers sought to better understand the device’s short-term performance. They enrolled 250 consecutive patients (mean age, 81 ± 6.2 years) who underwent transfemoral TAVR (transcatheter aortic valve replacement) with the valve, and analyzed Valve Academic Research Consortium (VARC-2) criteria outcomes at 30 days.
The median logistic EuroSCORE was 12.1% and the median Society of Thoracic Surgeons score was 4.4%.
Results revealed that 97.6% of patients experienced VARC-2-defined device success.
Overall, 5 patients had moderate paravalvular leakage, 1 died of a noncardiac cause, 8 had a stroke, 12 had life-threatening bleeding, and 9 had major vascular complications.
Between discharge and 30 days, the rate of hospitalization due to valve-related symptoms or worsening heart failure was 2%. Furthermore, the rate of the VARC-2 composite early safety end point was 10% and permanent pacemaker implantation was 15.2%.
There were no reported incidences of myocardial infarction, coronary obstruction requiring intervention, valve-related dysfunction, or endocarditis.
The researchers wrote that these findings reflect the initial experience of a single center.
“We found excellent outcomes using the [SAPIEN 3] THV with very low mortality and high device success rates,” they wrote.
Regarding the observed incidence of permanent pacemaker implantations and conduction abnormalities, the researchers noted that potential determinants include the high frame of the Sapien 3 THV and the deeper extension into the left ventricular outflow tract.
“However, the learning curve may play a role, and the appropriateness of manufacturer’s sizing recommendations may require critical appraisal,” they wrote. “Further research to identify the determinants of new conduction abnormalities is warranted to potentially reduce permanent pacemaker implantations using this novel device.”
Husser O, Pellegrini C, Kessler T, et al. Outcomes after transcatheter aortic valve replacement using a novel balloon-expandable transcatheter heart valve: a single-center experience. JACC Cardiovasc Interv. 2015;8(14):1809-1816. http://dx.doi.org/10.1016/j.jcin.2015.08.014.