For patients living with severe symptomatic aortic valve stenosis, the FDA has investigated and approved transcatheter aortic valve replacement (TAVR) as an effective treatment option. First performed in 2002, over 200,000 high- and intermediate-risk patients have already undergone the procedure, regaining function and living fuller, healthier lives.
Due to the success of the procedure among high-risk patient populations, research now focuses on TAVR for low surgical risk patients living with severe, calcific aortic stenosis. Currently, Sentara physicians perform TAVR for both high- and intermediate-risk patients via catheter-delivery with a transfemoral or transapical approach. This minimally invasive procedure helps patients recover faster and with less pain compared to traditional surgical methods of aortic valve replacement.
PARTNER 3 Examines TAVR Procedure in Low-Risk Patients
In collaboration with Edwards Lifesciences, physicians at the Sentara Cardiovascular Research Institute are currently enrolling eligible patients in the PARTNER 3 clinical trial. This prospective, randomized, controlled, multi-center study is part of the structural heart program at Sentara. The trial has been ongoing since April 2016. The estimated completion is early 2027.
Study goals include a better understanding of patient tolerance and outcomes related to TAVR when performed in low-risk populations compared to traditional surgical aortic valve replacement (SAVR). If proven effective, TAVR could become standard therapy in the treatment of aortic valve disease in low-surgical-risk patient populations.
Patients may be included in this clinical trial if they:
- Demonstrate a low-operative risk.
- Have severe, calcific aortic stenosis.
- Meet a surgical risk score (STS) of less than 4.
Patients selected for study participation are randomized into two groups and will receive either a TAVR with Edwards Lifesciences’ SAPIEN 3 heart valve or a traditional aortic valve replacement using a commercially available bioprosthetic valve. Generally, follow-up evaluations occur every 3 to 6 months after the initial surgical recovery period.
For every enrolled patient, researchers will measure the following for one-year post-op:
- All-cause mortality
- Stroke resulting from severe aortic stenosis
Secondary outcome measures include the length of index hospitalization for both the control and study groups and incidence of death or stroke.
Study Investigates Early TAVR for Patients with Asymptomatic Aortic Valve Disease
Patients living with asymptomatic severe aortic valve disease may also benefit from TAVR. Currently, investigations focus on whether this patient population experiences better outcomes and increased survival rates when we perform TAVR after the discovery of valve disease but before any symptoms develop.
Severe aortic valve disease is an incidental finding for most asymptomatic patients. We refer interested patients with this finding to specialists at Sentara Cardiovascular Research Center for the Early TAVR clinical trial.
Also in collaboration with Edwards Lifesciences, this study examines Early TAVR as an effective intervention to prevent death, stroke and other unplanned cardiovascular events.
For inclusion in the study, patients must undergo a cardiac stress test and remain asymptomatic. Then, patients are randomized 1:1. Therapeutic interventions include either clinical surveillance or Early TAVR with the SAPIEN 3 heart valve.
For patients enrolled in the Early TAVR study, primary outcome measures at two years include:
- Freedom from all-cause death
- All stroke events
- All unplanned cardiovascular hospitalizations
Secondary outcome measures include freedom from death or disabling stroke at two years post-op.
Aortic Valve Replacement: Current Outcomes and Looking Forward
While both studies are ongoing and no official clinical trial results are yet available, researchers report positive outcomes for patients enrolled in both Sentara Cardiovascular Research Institute studies.
Investigators stress that the clinical trials also look to prove the longevity of the valves used in both procedures. There is no long-term data supporting the efficacy of TAVR valves over an extended period.
Sentara Cardiovascular Research Institute welcomes your inquiries about the PARTNER 3 and Early TAVR clinical trials. Please contact Chelle Zulick at MRZULICK@sentara.comfor more information.