Structural valve deterioration has been observed to be a common thing amongst those with stark symptomatic aortic stenosis, who are being treated through surgical bioprosthesis as compared to the ones receiving supra-annular and self-expanding transcatheter heart valve (from Medtronic).
The findings mentioned above have combined the data from several trials, which are in turn, showing that rate at which structural valve deterioration happens within 5 years is around 4% as compared to 2.57% in those subject to TAVI (P = 0.0095)
These results were presented by Michael Reardon (Houston Methodist, Texas), MD, at the time of late-breaking clinical trial session at the American College of Cardiology (ACC) 2022 Scientific Session. He went on to explain the vitality of results, stating that they would help the physicians in conversing with the patients.
He has further mentioned that when he speaks to patients every week regarding feasibility of both – surgery and TAVI, the one question that lingers in their minds is – “How long would the valve last?”, upon which he replies – “What is the likelihood of the valve getting dysfunctional?”
Transcatheter Prostheses to be Superior?
Megan Coylewright, MD (Erlanger Health System, Chattanooga, TN), though not involved in study, did apprise TCTMD about the new data challenge, i.e. the initially prevalent assumption that surgical valves have a better longevity than transcatheter bioprostheses. Coylewright has moved ahead stating that durability was not the issue looked at before, but numerous patients with longer life expectancies were observed, who were advised to have surgical valve as they ascertain longer life.
Reardon said that surgeons, since ages, have been telling people that a surgical valve is needed to have longer-term data and have them lasting longer. However, with transcatheter prostheses in place, the notion is likely to change. Various heart specialists are likely to be roped for this discussion.
Richard Whitlock, cardiac surgeon associated with McMaster University/Population Health Research Institute, Canada (MD, PhD) is also known for handling TAVI cases. He clarified that CoreValve device has been doing exceedingly well over the last 5 years, so much so that it is overpowering surgical valves on the basis of hemodynamic criteria with regards to structural valve deterioration. He has, in fact, even appreciated investigators, stating that it’s, indeed, a good piece of news for the patients with no early signs of structural valve deterioration (with TAVI).
Whitlock has not shied away from stating that certain surgeons would be in complete disagreement with the results, but the ultimate objective would be to make the patients feel comfortable.
With Reardon saying that this would be the very first study to study the correlation between structural valve deterioration (defined in line with serial Doppler Transthoracic echocardiography) and adverse clinical outcomes, the EAPCI (European Association of Percutaneous Coronary Interventions) and (VARC) – 3 (Valve Academic Research Consortium) do not use this definition for structural valve deterioration. Reardon confirmed that the different definitions haven’t been validated with respect to clinical events.
With two types of outcomes at the two poles, the patients are certainly in for a surprise all through.