RE-ACCESS study has implications for TAVI valve selection

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Marco Barbanti

In recent years, transcatheter aortic valve implantation (TAVI) has expanded into a lower-risk, younger, patient population. These patients have a longer life expectancy compared to those historically treated using TAVI—bringing fresh considerations for the long-term requirements of the aortic valve. In this article, Cardiovascular News speaks to Marco Barbanti (AOU Policlinico “G Rodolico–San Marco”, Catania, Italy) to discuss the RE-ACCESS (Reobtain coronary ostia cannulation beyond transcatheter aortic valve stent) study, which examined the feasibility of coronary ostia cannulation after TAVI. Barbanti considers how the study’s findings influence valve selection.

As TAVI moves increasingly towards the lower-risk patient population, there is an increased need to consider the importance of preserving coronary access, according to Barbanti. “The durability of transcatheter aortic valves has already shown to be comparable to that of surgical valves up to eight years, and repeat TAVI to be a feasible option in case of prosthesis degeneration,” he comments. “The probability of the necessity of future coronary interventions is dramatically higher for younger patients, as it raises in function of life expectancy. Therefore, currently there is a growing interest in investigating the feasibility of coronary cannulation after TAVI, and how to reduce the risk of unsuccessful coronary re-engagement.”

Previous studies have reported heterogeneous data about the feasibility percutaneous coronary intervention (PCI) after TAVI. Overall, these demonstrated that coronary cannulation after TAVI is feasible in most cases, although there are differences between different transcatheter heart valve platforms, in particular those with supra-annular leaflets and closed-cell frames, which may be more prone to unsuccessful or even impossible coronary ostia engagement after TAVI, Barbanti says.

RE-ACCESS, an investigator-driven, single-centre, prospective, registry-based study is the first to investigate the issue of coronary access after TAVI from real-world practice. The primary endpoint of the study was the rate of coronary ostia cannulation failure after TAVI, and secondary endpoints included the identification of factors associated with the inability to selectively cannulate coronary ostia after TAVI.

“The reason for setting out such a study stemmed from the lack of certain data concerning the feasibility and reproducibility of coronary cannulation after TAVI, since available evidence mainly focused on CT-based prediction of potential coronary access after TAVI,” Barbanti, the chief investigator in the study comments.

A total of 300 patients undergoing TAVI using all commercially available devices were enrolled. Coronary angiography was performed on all patients before and after TAVI. After TAVI, a total of 23 (7.7%) cases of unsuccessful coronary cannulation were documented, most of them with the use of Evolut R/PRO transcatheter aortic valves (17.9% vs. 0.4%, p<0.01), Barbanti and colleagues reported in JACC: Cardiovascular Interventions in November 2020. Of the 23 cases of unsuccessful access,
22 involved the Evolut R/PRO platform (Medtronic), while one involved Sapien 3/Ultra (Edwards Lifesciences).

Among the important areas for discussion arising from the RE-ACCESS results, according to Barbanti, is the influence of the design of the prosthetic valve on the likelihood of success of coronary cannulation after TAVI. He said: “Results of this study confirmed a global perception that coronary cannulation through the Evolut [Medtronic] valve was more challenging than other TAVI platforms.” Barbanti commented that the rate of 17.9% of unsuccessful selective cannulation after Evolut (Medtronic) implantation reported in RE-ACCESS was “remarkably high”. “The lack of commissural alignment, along with specific features of the Evolut prosthesis—tall and closed-cell frame, and supra-annular leaflets—are the explanations for these findings,” he said.

ACURATE neo (Boston Scientific) is one such platform designed to preserve coronary perfusion and future coronary access with extra-wide stabilisation arches, supra-annular leaflets free from the stent frame and upper crowns designed to capture and cap the native leaflets. According to Barbanti, these features were confirmed in RE-ACCESS. He said: “We showed that all patients receiving the self-expanding ACURATE neo had a successful post-TAVI coronary ostia cannulation; although this is supra-annular, we hypothesised that the very large cells and the upper crown of the frame that avoids the native cusps to fold up towards the coronary ostia, contributes in facilitating coronary cannulation.”

Asked whether the findings should influence the choice of valve depending on the type of patient undergoing the TAVI procedure, Barbanti notes that the need to consider preservation of future manageable coronary access after TAVI is increasingly becoming a priority, particularly in younger patients and in those presenting concomitant coronary artery disease. In this context, a transcatheter aortic valve that was demonstrated to not preclude coronary cannulation through its frame should be considered the best practice, he says.

“The results of this study should stimulate the development of future generation transcatheter aortic valves with very large cells facing the coronary ostia and incorporating a reliable mechanism to align the prosthetic valve commissures with those of the native valve, thus optimising its placement in relation to the coronary arteries,” he concludes.


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