At EuroPCR, the Congress of Interventional Medicine, held in Paris in May 2015, the latest results of various studies on TAVI (transcatheter aortic valve implantation) were presented, among other topics. These included results from the 1-year follow-up of the SAPIEN 3 trial and early data from intermediate-risk TAVI patients.
The Edwards SAPIEN 3 valve represents the latest generation of aortic valve prostheses delivered via transcatheter aortic valve implantation (TAVI). This procedure is primarily used to treat aortic stenosis in patients at high surgical risk. In intermediate-risk patients, TAVI is currently under discussion.
High survival rates after TAVI
The ongoing prospective, multicenter, nonrandomized SAPIEN 3 trial is evaluating outcomes, survival rates, and adverse event rates of TAVI with the SAPIEN 3 valve – the latest results, collected after 1-year follow-up, were presented by John Webb, MD, St. Paul’s Hospital, Vancouver, Canada, at the EuroPCR Congress. Data from 150 patients with severe aortic stenosis and high (STS score ≥8 or EuroSCORE ≥15) or intermediate (STS score ≥4 or EuroSCORE ≥10) surgical risk were analyzed. These patients were treated with the SAPIEN 3 valve between January and November 2013 in 16 centers in Germany, Italy, France, the United Kingdom and Canada. Access was transfemoral in 96 (64%) patients and transapical or transaortic in 54 (36%).
The 1-year survival rate of transfemoral-treated patients was 91.6%. This is the highest 1-year survival rate ever achieved in a multicenter TAVI trial. The figure is particularly remarkable when one considers the average age of the study participants: After all, it is 83.6 years.
There were many comorbidities in the study population and the mean EuroSCORE score was high: 19.8 in the transfemoral group, 24.9 in the transapical or transaortic group. Nevertheless, TAVI patients had a survival rate almost as good as the normal population, in which the 1-year survival rate of 84-year-old individuals is 92.5%.
Risk for stroke is low
The incidence of stroke in the transfemoral access patient group was 2.1% (with 1.1% with permanent disability), which was very low. In the period between day 30 and one year after the intervention, only one patient had suffered a stroke. Mild or moderate paravalvular leakage occurred in 2% of patients during the first year after TAVI, but severe cases of paravalvular leakage did not occur within the study; there was also no case of valve thrombosis or valve displacement.
Good hemodynamic function of the implanted aortic valves was preserved in all patients at 1 year: 37% of patients were in NYHA class I, 56.5% in class II, 4.8% in class III, and 0.8% in class IV (before the procedure class I: 0%, class II: 16.1%, class III: 77.4%, class IV: 6.5%).
All-cause mortality at one year was 8.4% (cardiac mortality 2.1%) in the transfemoral access group and 24.3% (cardiac mortality 13.3%) in the other access group. A permanent pacemaker had to be used in 15.7% (transfemoral access) resp. 19.8% (other access) of patients were used.
TAVI also for patients with intermediate surgical risk?
Currently, the SAPIEN 3 valve is approved in Europe for the treatment of patients with aortic stenosis who are inoperable or patients at high surgical risk. Given the good results in these patients, the question is whether TAVI might not be an alternative to surgery for older patients with severe aortic stenosis and intermediate risk, Dr. Webb said. The first results of the corresponding study (extension of the SAPIEN 3 study) were also presented at the congress.
The multicenter study followed 101 patients with severe aortic stenosis and intermediate surgical risk (STS score ≥4 and ≤8 or EuroSCORE ≥10 and ≤15) from 13 centers in Europe and Canada. All-cause mortality was 1% at 30 days after TAVI. Significant complications occurred infrequently: stroke in 2% of patients, major vascular events in also 2%, new implantation of a permanent pacemaker in 4%, moderate paravascular leaks in 2.3%, and no severe leaks. These early results suggest a high safety of TAVI even in patients with intermediate surgical risk.
Source: EuroPCR, Congress of Interventional Medicine, May 17-20, 2015, Paris.
HAUSARZT PRAXIS 2015; 10(7): 24-25
CARDIOVASC 2015; 14(4): 30-31
