Low 1-Year Event Rates Seen After TAVR With Sapien 3
The Sapien 3 valve provides low rates of mortality and disabling stroke, sustained symptomatic improvement and consistent hemodynamic valve performance out to 1 year in high-risk and inoperable patients undergoing transcatheter aortic valve replacement (TAVR), according to updated results from the PARTNER II trial presented during a late-breaking trial session at TCT 2015.
Howard C. Herrmann, MD, of the Hospital of the University of Pennsylvania, Philadelphia, Pa., reported on the 583 high-risk or inoperable patients (mean age 82 years; 42% women) who underwent TAVR with the Sapien 3 valve (Edwards Lifesciences) at 29 U.S. sites. At baseline, inoperable patients had a significantly lower median STS score (7.4 vs. 8.6; P = .002) and were more likely to have oxygen-dependent chronic obstructive pulmonary disease, hostile chest and frailty.
At 1 year, overall survival was 85.6%, with slightly better outcomes among high-risk vs. inoperable patients (87.3% vs. 82.3%; P = .14). Survival was also higher among patients who underwent transfemoral as opposed to transapical or transaortic procedures (87.7% vs. 74.7%; P = .0006).
The overall rate of disabling stroke (modified Rankin Scale score ≥ 2 as adjudicated by clinical events committee) was 2.4%, with no differences by access type or between high-risk and inoperable patients. There were no cases of structural valve deterioration or valve thrombosis, and 16.9% of patients required a new permanent pacemaker.
Symptomatic improvements seen at 30 days were sustained at 1 year. The percentage of patients with NYHA class III/IV symptoms declined from 90.1% at baseline to 7.7% at 1 year. Improvements in mean gradient and aortic valve area observed at 30 days were maintained through longer follow-up, as well.
The distribution of paravalvular regurgitation was similar at 30 days and 1 year. At the latter time point, regurgitation was mild in 29.1% and moderate in 2.7%, with no severe cases. Mild regurgitation at 30 days was not associated with poorer survival at 1 year, but patients with moderate regurgitation had a survival rate of just 61.9%. Herrmann noted, however, that only 16 patients were in the moderate group at 30 days.
TAVR ‘preferred’ in high-risk, inoperable patients
“We believe that the combination of the new design features of Sapien 3, procedural improvements, operator experience and improved patient selection have all contributed to a low rate of important adverse events, including stroke, and a high rate of 1-year survival in these high-risk and inoperable patients,” Herrmann concluded. The results “support the use of TAVR as the preferred therapy in high-risk and inoperable patients with aortic stenosis.”
Herrmann pointed out that there has been about a 50% relative reduction in 1-year mortality when comparing the current results with those from the PARTNER I trial.
The results are reassuring, Jeffrey J. Popma, MD, of Beth Israel Deaconess Medical Center, Boston, Mass., said at a press conference. But, he added, it is difficult to interpret the reduction in mortality over time because much of the improvement is related to better patient selection.
Popma agreed, though, that these data add to the evidence supporting TAVR as the preferred therapy in high-risk and inoperable patients with aortic stenosis. “We’ll be gaining incremental information, and the confidence with our statements about preferred therapy just become stronger as we get data like this,” he said.
Popma added that the low rate of disabling strokes was reassuring, but he said that more subtle neurocognitive changes have probably been missed, highlighting the importance of deciding how to handle diffusion-weight MRI findings. “At the end of the day, I think as we search for strokes we’ll find that [there are] probably some more neurologic implications to this.”
- Herrmann reports receiving grant/research support from Abbott Vascular, Boston Scientific Corporation, CardioKinetix, Edwards Lifesciences, Gore, Medtronic, MitraSpan, Siemens and St. Jude Medical, receiving honoraria from Edwards Lifesciences and holding equity in Micro Interventional Devices.
- Popma reports relationships with Abbott Vascular, Boston Scientific Corporation, Cook Medical, Direct Flow Medical and Medtronic.