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PARTNER 1: TAVR, surgical AVR durable at 5 years
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Transcatheter aortic valve replacement appears to be a durable treatment for severe aortic stenosis, according to the results of a 5-year postimplantation study published in JAMA Cardiology.
TAVR is a safe and effective treatment for severe aortic stenosis, but until recently, there were limited data available on its durability, according to the study background.
“Late deterioration of surgically implanted bioprosthetic valves is well-described, with the reduced need for anticoagulation compared with mechanical valves seen as an acceptable tradeoff for potential reintervention,” Pamela S. Douglas, MD, the Ursula Geller Professor for Research in Cardiovascular Diseases at Duke University School of Medicine, and colleagues wrote. “While this risk vs. benefit equation may be especially appealing in the elderly population currently receiving TAVRs, reports of early leaflet thickening and possible valve thrombosis demand further investigation.”
To determine the midterm hemodynamic performance of balloon-expandable transcatheter heart valves (Sapien, Edwards Lifesciences), researchers analyzed core laboratory-generated data from ECGs of 2,795 patients enrolled in the PARTNER 1 trial with successful TAVR or surgical AVR obtained before implantation at 7 days, 1 and 6 months, and every year for 5 years after implantation.
Primary outcomes for the study included death or reintervention for aortic valve structural indications, which were measured using aortic valve mean gradient, effective orifice area and Doppler velocity index. Other outcomes included evidence of hemodynamic deterioration by reintervention, adverse hemodynamics or transvalvular regurgitation.
Douglas and colleagues included echocardiograms of 424 patients (mean age, 85 years) 5 years after TAVR.
In the first months following after TAVR, population hemodynamic trends from nonlinear mixed-effects models showed small positive changes and a decrease in aortic valve mean gradient, an increase of 0.028 in Doppler velocity index and a 0.09 cm2 increase in effective orifice area, according to the researchers.
Thirty-four percent of the 2,404 patients treated with TAVR survived 5 years, as did 37% of the 313 patients treated with surgical AVR, they wrote.
A second valve procedure was necessary for 0.8% in the TAVR cohort and 0.3% in the surgical AVR cohort, and only five instances of reintervention due to structural deterioration of the transcatheter valves were necessary, according to the researchers.
According to a press release from Duke University Medical Center, the study provides a first step in understanding the long-term benefits of TAVR and suggests that further study can be safely conducted.
“These findings are incredibly reassuring at least out to 5 years,” Douglas said in the release. “The valve is durable and safe.” – by Dave Quaile
Disclosures: The study was funded by Edward Lifesciences. Douglas reports she leads the PARTNER 1 echocardiography core laboratory. Please see the study for all other authors’ relevant financial disclosures.
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