The annual meeting of the European Society of Cardiology, in Paris, has enhanced the status of TAVI as the “gold standard” for inoperable patients suffering from severe aortic stenosis. However, concerns about high rates of permanent pacemaker implantation after TAVI remain, specialists say.
TAVI was introduced nearly 10 years ago as an alternative procedure with limited application but it has expanded significantly in the course of recent years. Despite its increasing popularity among physicians, however, haemodynamic performance and valve durability remain unknown.
Now, for the first time, data from 393 consecutive patients undergoing implantation of a CoreValve self-expandable prosthesis at the German Heart Centre in Munich, Germany, have been presented: they show a “sustained improvement of haemodynamic values” and no signs of early or “unexpected” deterioration of the valve at three-year of follow-up.
“We all know that any biological valve gets deteriorated after a certain period of time, would this be 10 or 12 years. We know exactly when this will occur to a traditional heart valve, but we do not know when this will occur to a transcatheter valve. Now we know that after three years the haemodynamic performance of transcatheter valves is unchanged,” Anke Optiz, co-investigator of the study, told Cardiovascular News.
Based on the societies guidelines, so far most of the TAVI registries have included patients with high logistic Euroscore (20% or higher). However data presented at ESC this year suggest that 100% procedural success is possible even in a patient population with lower logistic Euroscore. The prospective, single-centre data refer to a cohort of 177 patients who underwent implantation with the Edwards valve at the Rouen University Hospital, France, between May 2006 and January 2011.
“We examined the population with lower logistic Euroscore because we were under the impression that these patients reacted better to TAVI as they were younger and had fewer comorbidities,” said Matthieu Godin, co-investigator of the study. “The retrospective analysis showed absence of death at 30 days for this specific group of low-risk patients. This result was beyond our expectations,” he added. Despite this data, Godin noted, “we should never forget that conventional surgery remains the gold standard for the lower-risk patient population”.
The Rouen experience is not isolated. An increasing trend to include lower risk patients into TAVI registries has been observed across European countries in the last few years. But according to both cardiology and cardiac surgery specialists discussing TAVI at ESC, this should not become standard practice.
“We can say that TAVI is doing relatively well – better than conventional surgery – within a certain high-risk group. But it is difficult to say that TAVI will necessarily do better in the lower group as well, because we do not have evidence of better results with TAVI compared to conventional surgery in any trial, including the US PARTNER trial where TAVI results are extremely good,” Olaf Wendler, clinical director, Cardiothoracic Surgery, King’s College Hospital, London, UK, told Cardiovascular News. “That is why I think TAVI should focus on patients who would clearly benefit from this new treatment immediately.”