A study published ahead of print in Circulation Cardiovascular Interventions indicates that post dilation in patients with greater than mild paravalvular regurgitation following a balloon-expandable transcatheter aortic valve implantation (TAVI) procedure is safe and effective
Benoit Daneault (Columbia University Medical Center/New York Presbyterian Hospital/Cardiovascular Research Foundation, New York, USA) and others reported that even mild paravalvular regurgitation, following a TAVI procedure, has been associated with increased mortality. They added that although post dilation of balloon expandable valves after implantation has been proposed as an effective method of reducing paravalvular regurgitation, the potential risks of the procedure (which include transcatheter heart valve migration or injury) “may outweigh the potential benefits from reduction in aortic regurgitation”. Thus, the aim of their study was “to evaluate the efficacy of post dilation of balloon expandable transcatheter heart valves at reducing paravalvular regurgitation and its clinical safety.”
Daneault et al assessed data from consecutive patients who had been treated with the balloon expandable Sapien or Sapien XT valves (both Edwards Lifesciences) as part of the PARTNER and PARTNER 2 studies between 2007 and 2011. Post dilation was performed in patients who had “more than mild” paravalvular regurgitation immediately after implantation of the valve. Clinical endpoints, the authors explained, included 30-day mortality, in-hospital stroke or transient ischaemic attack, procedure related major aortic injury, and need for new permanent pacemaker during the index procedure.
Of 259 patients who received a Sapien or Sapien XT valve at the authors’ institution, 106 underwent a post dilation procedure for more than mild paravalvular regurgitation (as assessed on transoesophageal echocardiography). Daneault et al commented that patients who received post dilation were taller, heavier, more often male, and had lower Society of Thoracic Surgeons (STS) scores than patients who did not receive the procedure.
They reported that there were no cases of valve embolisation during post dilation and that no patient needed a second heart valve after post dilation. They also commented: “There was no statistically significant difference between the two groups in the incidence of neurological events, although they were more frequent in patients with post dilation.”
Furthermore, Daneault et al noted that the rate of permanent pacemaker implantation was not significantly different between patients who underwent post dilation and those who did not, and that the rate of paravalvular regurgitation was significantly reduced following post dilation.
According to the authors, their study has shown that “judicious use of post dilation for greater than mild paravalvular regurgitation is not associated with excess morbidity or mortality.” However, they concluded that “larger clinical studies are needed to confirm these findings, especially to assess the risk of cerebrovascular events.”