The use of transcatheter aortic valve implantation (TAVI) has grown rapidly over the last decade1
This is due to the innovations in valve prostheses and delivery systems, improvements in clinical outcomes1 (evidenced within clinical trials such as PARTNER I and II, and more recently PARTNER 3)2-6,8-12 and the expanded indication for the use of TAVI.6
In the 2017 ESC/EACTS Guidelines,7 the use of TAVI, as an alternative to surgical aortic valve replacement (sAVR), was expanded from high risk patients (EuroSCORE II surgical risk score ≥10%),2 to patients at increased surgical risk (EuroSCORE II ≥4%), based on a robust clinical evidence base.
Patients at increased surgical risk include those previously studied in clinical trials, such as PARTNER I5 and II12 ,classified as high and intermediate risk (EuroSCORE II ≥4‒8%) respectively.
Recent trials have investigated the safety and efficacy of TAVI in low-risk patients (EuroSCORE II <4%). The PARTNER 3 Trial was a multicenter, randomized trial in which TAVI with transfemoral placement of a third-generation balloon-expandable valve compared with surgical aortic-valve replacement in patients with severe aortic stenosis at low risk. PARTNER 3 Trial proved SAPIEN 3 TAVI is superior to sAVR on the primary endpoint (all-cause death, all stroke, and rehospitalization) and multiple pre-specified secondary endpoints.
PARTNER 3 Trial: Comparing SAPIEN 3 TAVI with sAVR in low-risk sSAS patients9
Previous PARTNER trials showed that, in patients who were at intermediate or higher risk of death with surgery, TAVI was either superior or non-inferior to standard therapies, including sAVR.2-5 The PARTNER 3 Trial compared the outcomes of TAVI with sAVR in patients with severe symptomatic aortic stenosis at low surgical risk.
Explore the unprecedented outcomes from PARTNER 3 Trial here.
PARTNER II Trial: TAVI versus sAVR in intermediate risk patients (EuroSCORE II ≥4‒8%)
The PARTNER II trial data were pivotal in providing supporting evidence demonstrating the clinical superiority of TAVI via the transfemoral approach versus sAVR in patients at intermediate surgical risk.
Following innovations in the TAVI prosthesis and delivery system, the PARTNER IIA trial and S3i propensity analysis data2,3 were able to demonstrate that, in patients at intermediate surgical risk, transfemoral access TAVI resulted in significantly lower rates of the combined endpoint of mortality, all-stroke and moderate/severe aortic regurgitation at 1 year and a lower rate of death or disabling stroke at 2 years compared with sAVR.2
Patients who received TAVI via transfemoral access returned to their normal, daily activities faster than patients who received sAVR.3
PARTNER I Trial: TAVI versus sAVR in high risk and inoperable patients
In 2007, Edwards Lifesciences initiated the first ever randomised TAVI trial, PARTNER.5,8 This paradigm-shifting study was designed as two parallel and individually powered trials investigating 1057 patients at high surgical risk (EuroSCORE ≥10%). The two cohorts compared established treatments in patients considered by the Heart Team to be operable (TAVI versus sAVR) or inoperable (standard therapy or balloon aortic valvuloplasty versus TAVI). The PARTNER trial results were ground breaking, showing significantly improved all-cause mortality at 1 and 5 years in inoperable patients previously treated with standard therapy.6, 8
In patients at high surgical risk, TAVI demonstrated similar rates of all-cause mortality to sAVR at both 1 and 5 years’ follow-up.4, 5
Cohort A – TAVI vs. sAVR in high-risk patients4
Cohort B – TAVI vs. standard therapy in inoperable patients6