All sizes of the Portico transcatheter aortic valve replacement (TAVR) system showed effective treatment in a short-term study of 222 high-risk patients.
Lead researcher Helge Möllmann, MD, of St. Johannes Hospital in Dortmund, Germany, and colleagues published their findings online in JACC: Cardiovascular Interventions.
The nonrandomized study examined patients with severe aortic stenosis at multiple locations. They were implanted with the full range of Portico heart valves (23, 25, 27 and 29 mm) and evaluated after 30 days. A total of 220 patients received the valves; two procedures were unsuccessful.
At 30 days post-operation, all-cause mortality was 3.6 percent, while 3.2 percent of patients suffered a major stroke, 7.2 percent demonstrated major vascular complications and 13.5 percent required a permanent pacemaker implantation.
Compared with baseline condition, 75.8 percent of patients improved by at least one New York Heart Association functional class at 30 days. Möllmann and colleagues noted no major difference in effectiveness between the valve sizes.
“Evaluation of the short-term safety and performance of the full range of Portico transcatheter aortic heart valves resulted in the following key findings: 1) device implantation is safe and is associated with a low 30-day mortality and disabling stroke rate; 2) the resheathable feature is clinically meaningful and allows the operator to optimize the valve position to achieve a high implantation success rate; and 3) there are no marked differences among the various valve sizes related to procedural success, valve performance or vascular access complications,” they wrote.
In addition to being nonrandomized, the study had the following limitations, according to the authors: It didn’t allow any direct comparison with other valves, the procedures used only the transfemoral approach rather than the transapical approach, and each of the investigators had no previous experience with the Portico TAVR system.
“Given that there was no roll-in patient phase, outcomes should be interpreted in view of the operators’ early learning curve, which may underestimate the short-term safety and performance that may be achieved by operators who have gained more experience with the Portico TAVR system,” Möllmann and colleagues wrote.