This morning at TVT 2019 (12-15 June, Chicago, USA), in separate presentations, the principal investigators of PARTNER 3 and Evolut Low Risk trials both said that the findings of the studies indicate that transcatheter aortic valve implantation (TAVI) should be the preferred option for appropriate low-risk patients. These statements follow that of PCR at EuroPCR 2019 in which PCR said that these studies, alongside other TAVI data, have led to a series of paradigm shifts in the management of severe aortic stenosis.
In the TVT session “The TAVI Low Risk RCTs: Crystallising the data and clinical implications”, PARTNER 3 investigator Michael Mack (Baylor Scott and White Health, Plano, USA) provided an overview of the key findings of the trial. He noted that it showed that, at one year, the rate of the composite of death, stroke, or rehospitalisation was significantly lower in low-risk patients undergoing TAVI (with the Sapien 3, Edwards Lifesciences) than those undergoing surgery. He said: “Based upon these findings, TAVI through one-year should be considered the preferred therapy in low surgical risk aortic stenosis patients”. He added, collectively over the last 12 years, the PARTNER randomised trials clearly indicate “the relative value of TAVI compared with surgery is independent of surgical risk profiles”. However, Mack stated the choice to use TAVI vs. surgery should be a “shared-decision making process” that takes account of “patient preferences, understands the knowledge gaps–especially in younger patients–and considers clinical and anatomical implications”.
Following Mack, Jeffrey Popma (Beth Israel Deaconess Medical Center, Boston, USA) spoke about the highlights of the Evolut Low Risk trial (of which, he was principal investigator). The study showed that, at two years, TAVI with CoreValve (Medtronic) was non-inferior to surgery in patients at low surgical risk in terms of a composite endpoint of death or disabling stroke. According to Popma, the study also found that TAVI had a “better safety and recovery profile” than surgery as it was associated with less death or disabling stroke, less disabling stroke, shorter length of stay, and better quality of life. However, he did note surgical patients had fewer pacemakers implanted and less residual aortic regurgitation. “I have to agree with Dr Mack, TAVI is preferred to surgical aortic valve replacement in appropriate patients deemed low risk for surgery,” Popma concluded.
After Mack and Popma gave their respective presentations, a cardiologist and a surgeon–Blase A Carabello (East Carolina Heart Institute, Brody School of Medicine, East Carolina University, Greenville, USA) and Patrick McCarthy (Division of Cardiac Surgery, Northwestern University Feinberg School of Medicine, Northwestern University, Chicago, USA), respectively–gave their perspectives on the studies. Carabello noted that the heart team will become “more important going ahead” as they will be need to be able to tell patients “I know you’ve heard about TAVI. It should be used in those patients but it should not be used in you for [such and such] reasons”. McCarthy also gave a cautious response: “As surgeons with grey hair, we have been disappointed before [i.e. with homografts]. Are we going to create the same with TAVI [i.e. be disappointed again]? We don’t know yet.” However, he did observe that, at present, “there aren’t that many” patients who have come back for reoperation.