New-generation transcatheter heart valves (THVs) may mean that the degree of aortic angulation (AA) no longer plays a role in procedural success or in-hospital outcomes, new data suggest.
The study investigated whether the AA affects outcomes after transcatheter aortic valve replacement (TAVR) using newer-generation THVs among 841 patients across all risk strata who underwent transfemoral TAVR using balloon-expandable (BE) or the self-expanding (SE) THVs.
Published online Monday, ahead of its appearance in the June 14 issue of JACC: Cardiovascular Interventions, the study concludes that AA “no longer plays a role with new-generation BE or SE THVs in contemporary TAVR practice.”
Giorgio A. Medranda, MD, and colleagues, of MedStar Washington Hospital Center, noted that an AA of 48 degrees or greater has been reported to adversely influence accurate THV deployment, procedural success, fluoroscopy time, and paravalvular leak (PVL) in patients undergoing TAVR with SE THVs.
While the new study reported that an AA of 48 degrees or more did not affect procedural success or in-hospital outcomes, an accompanying editorial warned that because the results of the trial go against previous results, the findings should be treated with caution for now.
“It is my opinion that such a conclusion may be slightly premature,” commented editorialist Yigal Abramowitz, MD, of Ben-Gurion University of the Negev, Israel, adding that contradictory results of several previous trials “may imply that more data are needed to reassure us that increased AA is no longer a substantial challenge with new-generation SE devices.”
Furthermore, he added that the study presents the experience of a single, high-volume TAVR center, warning that results in less experienced centers may differ.
“Nonetheless, the progress in understanding the impact of AA on TAVR outcomes and the results of the present study demonstrate how significant improvements in preprocedural planning and technological upgrades of new-generation devices play part in safely expanding TAVR to a more diverse patient population,” said Abramowitz, adding that multicenter observational trials as well as meta-analyses and, ideally, randomized clinical trials may help to confirm the conclusions of the new study.
The retrospective observational study analyzed data from 841 patients who underwent transfemoral TAVR using BE SAPIEN 3 or the SE CoreValve Evolut PRO from 2015 to 2020, with the previously published cutoff of 48 degrees used to analyze procedural success and in-hospital outcomes according to THV type.
Medranda and colleagues reported that an AA of 48 degrees or greater did not influence outcomes in patients with BE THVs.
Additionally, they said the same 48-degree cutoff did not influence procedural success (99.1% vs. 99.1%; p = 0.980), number of THVs used (1.02 vs. 1.04; p = 0.484), rates of more than mild PVL (0.4% vs. 0%; p = 0.486), new permanent pacemaker implantation (11.8% vs. 17.1%; p = 0.178), in-hospital stroke (3.9% vs. 1.8%; p = 0.298), or in-hospital death (0.4% vs. 0.9%; p = 0.980) in patients with SE THVs.
As a result, they concluded that the current data suggest that AA no longer plays a role in success outcomes with new-generation BE or SE THVs in contemporary TAVR practice.
An AA of 48 degrees or greater did not affect procedural success or in-hospital outcomes and should no longer be a consideration when determining THV selection, they said.
Alongside his more general warning for caution in his accompanying editorial, Abramowitz noted that the new study does not address the issue of device implantation in patients with “extreme AA” – also referred to as “horizontal aorta” – who have an AA of greater than 70 degrees.
He noted that these patients have been excluded from previous clinical trials of SE TAVR, while in the current study only 9 of 841 (1%) patients were classified as “extreme AA”. Of these, only three were treated with SE devices.
Because of this, he added that meaningful conclusions with regard to safety of the procedure in such patients cannot be drawn.
Medranda GA, Musallam A, Zhang C, et al. The Impact of Aortic Angulation on Contemporary Transcatheter Aortic Valve Replacement Outcomes. JACC Cardiovasc Interv 2021;14:1209–15.
Abramowitz Y. Aortic Angulation and Self-Expandable Transcatheter Aortic Valve Replacement Outcomes: The Wider Angle. JACC Cardiovasc Interv 2021;14: 1216-7.