Five-year bioprosthetic valve dysfunction data for Medtronic’s CoreValve and later-generation Evolut transcatheter aortic valve implantation (TAVI) platforms have been presented at the 2023 Cardiovascular Research Technologies (CRT) conference (25–28 February, Washington DC, USA).
According to Medtronic, the results indicate that the CoreValve and Evolut are the first and only TAVI platforms to show significantly better valve performance and durability compared to surgical aortic valve replacement (SAVR) at five years. Data, presented by Steven Yakubov (Riverside Methodist Hospital, Columbus, USA) in a late-breaking clinical trial session at CRT 2023, build upon the results of the structural valve deterioration analysis recently published in JAMA Cardiology.
“These results add yet another proof point demonstrating the durability benefits of TAVI compared to surgery when it comes to bioprosthetic valve dysfunction—a complication that can impact the durability and performance of a critical valve replacement,” said Yakubov. “With valve durability becoming more critical as TAVI expands to younger, healthier patients, this analysis underscores the long-term promise of this minimally invasive approach and should be taken into consideration during initial valve selection.”
The study retrospectively analysed 1,128 TAVI and 971 surgery patients from the CoreValve US High Risk and SURTAVI randomised trials. The pooled analysis of the CoreValve US Pivotal and SURTAVI Trials evaluated valve performance and durability of surgical and transcatheter valves by incidence of overall bioprosthetic valve dysfunction which includes structural valve deterioration, non-structural valve dysfunction, thrombosis, and endocarditis. This is the first comprehensive analysis to support clinical criteria for valve performance and durability using all four components of bioprosthetic valve dysfunction and its association with clinical outcomes.
“These extraordinary results reinforce the haemodynamic durability and valve performance of the CoreValve/Evolut system and demonstrate again that Evolut is a safe and effective alternative to surgery,” said Nina Goodheart, senior vice president and president of the Structural Heart & Aortic business, which is part of the Cardiovascular portfolio at Medtronic. “As a pioneer and leader in the early treatment of aortic stenosis, Medtronic strives to continually improve our CoreValve/Evolut platform to ensure it is meeting the needs of the physicians and the growing patient population that will benefit from this type of procedure.”
In the study, CoreValve/Evolut had a significantly lower bioprosthetic valve dysfunction cumulative incidence rate compared to surgery (7.8% vs. 14.2%; p<0.001). Five-year rates of structural valve deterioration and non-structural valve dysfunction were significantly lower after TAVI compared to surgery [structural valve deterioration—TAVI 2.2% vs SAVR 4.4%; p 0.004, non-structural valve dysfunction—TAVI 4.3% vs SAVR 8.8%; p<0.001].
TAVI also demonstrated three times lower severe prosthesis-patient mismatch (PPM) (3.7% vs. 11.8%; p<0.001) at 30-days/discharge compared to surgery, which occurs when the valve is too small for the patient’s body size. There were no significant differences in rates of thrombosis (0.3% TAVI vs 0.2% SAVR, p=0.80) or endocarditis (1.1% TAVRI vs. 1.3% SAVR, p=0.68).
Patients in both groups who developed bioprosthetic valve dysfunction through five years were at about 1.5-fold greater risk of death or hospitalisation for valve-related disease or heart failure as patients who did not develop bioprosthetic valve dysfunction.
The CoreValve US Pivotal High-Risk trial was a prospective, randomised, multicentre, non-inferiority study that compared the safety and efficacy of the Medtronic CoreValve system to SAVR in patients with symptomatic severe aortic stenosis at increased surgical risk. The SURTAVI Trial was a prospective, randomised, multicentre, non-inferiority study to assess the safety and efficacy of the Medtronic TAVI system to SAVR in patients with symptomatic severe aortic stenosis at intermediate surgical risk.