The newer iteration of the self-expanding Evolut valve was associated with small hemodynamic improvements when used for transcatheter aortic valve replacement (TAVR) in a degenerated surgical bioprosthesis notwithstanding a safety signal in real-world data.
The Evolut PRO kept mean gradients lower compared with the Evolut R (13.2 vs 14.3 mm Hg at 1 year, P=0.023) and was tied to a bigger post-procedure effective orifice area (1.6 vs 1.5 cm2, P=0.022) based on data from the STS/ACC TVT Registry, said Guilherme Attizzani, MD, of UH Harrington Heart and Vascular Institute in Cleveland, at the Transcatheter Valve Therapy (TVT) virtual meeting.
Evolut PRO had been designed by adding an outer porcine pericardial wrap to the Evolut R in order to prevent paravalvular leak. A third-generation model, the Evolut PRO+, received FDA approval in late 2019.
Attizzani reported that clinical outcomes over 30 days were no different between Evolut PRO and Evolut R recipients in terms of:
- All-cause mortality: 2.8% vs 2.5%)
- Stroke: 1.8% vs 2.2%)
- MI: 0.6% vs 0.3%)
- Pacemaker or implantable cardioverter-defibrillator implants: 3.0% vs 5.3% excluding patients with these devices at baseline
Thus, either valve presents “a safe and effective treatment for patients with a failing surgical bioprosthesis,” the researcher concluded.
However, differences emerged by 1 year: the Evolut PRO group had fewer pacemaker and ICD implants (4.5% vs 7.4% for Evolut R, P=0.007) at the expense of an elevated incidence of MI (1.8% vs 0.8%, P=0.020).
TVT session discussant Subhash Banerjee, MD, of UT Southwestern Medical Center in Dallas, highlighted the higher MI rate and potential concerns about undetected coronary obstruction with the Evolut PRO.
One question is whether the improved hemodynamics of the Evolut PRO can be attributed to the device itself or better operator experience, suggested J. Dawn Abbott, MD, of Warren Alpert Medical School of Brown University in Providence, Rhode Island, during the discussion.
For the study, Attizzani’s group included 5,897 cases of TAVR in surgical valves, divided between Evolut PRO (n=836) and Evolut R cases (n=5,061).
The two groups shared similar baseline characteristics (mean age 75.1; 58.7% men; STS-PROM score 7.7%). The Evolut PRO arm was less likely to undergo general anesthesia (53.5% vs 59.9%, P<0.001) and generally had bigger valves implanted.
Lower gradients were seen with increasing device size, according to the investigator.
Post-procedure paravalvular regurgitation (PVR) initially favored the Evolut PRO group over Evolut R recipients. However, there was no difference by 1 year, when about 85% of overall cohort was free of any PVR.
Similarly, Evolut PRO’s early reduction of total aortic regurgitation (AR) dissipated by 1 year, when over 80% of patients had none or trace AR.
Among the limitations of relying on the TVT registry for the study were that investigators could not determine the type of surgical valve implanted nor the mode of failure. Also, information on valve fracture was not captured by the registry.
Furthermore, only two-thirds of the included patients had 1-year follow-up data, and the outcomes were not adjusted for baseline differences between groups, Attizzani cautioned.
Medtronic personnel performed statistical analysis and graphic creation for the study.
Attizzani disclosed relevant relationships with Edwards Lifesciences, Medtronic, and Abbott Vascular.