A study has found that a transcarotid approach to transcatheter aortic valve replacement (TAVR) with the Edwards Sapien 3 transcatheter heart valve was safe and associated with successful implantation in the majority of elderly patients with severe symptomatic aortic stenosis and high or prohibitive surgical risk. Findings from this study were published in the Journal of the American College of Cardiology Cardiovascular Interventions.
Researchers identified a total of 314 patients (median age, 83 years; interquartile range, 78-88 years) from the French Transcarotid TAVR prospective multicenter registry who presented with severe symptomatic aortic stenosis who were at a high or prohibitive surgical risk (Society of Thoracic Surgeons mortality risk score, 5.8%; interquartile range, 4%-8.3%).
All patients were considered for TAVR, and vascular anatomy was assessed to confirm a suitable treatment approach. The investigators assessed the associated procedural success, as defined by a successful implantation of a single transcatheter heart valve in the appropriate aortic position and without aortic rupture. In addition, 30-day mortality, morbidity, and cerebrovascular outcomes were assessed.
Procedure failures were observed in only 3% of patients, all of whom required a valve-in-valve procedure for persistent severe angiographic aortic regurgitation. Mortality was 100% in patients with procedure failure, attributable to 3 annulus ruptures.
Conversely, there was a procedural success rate of 97%, with most cases using the left carotid artery for transcarotid-TAVR implantation (73.6%). Only 13 patients (4.1%) experienced major bleeding, and only 1 patient experienced major bleeding because of carotid access.
At 30-day follow-up, 16.2% of patients required a permanent pacemaker, whereas 5.1% had moderate to severe paravalvual leak.
The incidence of stroke or transient ischemic attack occurred in 1.6% of the final cohort. Strokes and transient ischemic attack occurred within 24 hours of implantation and 10 to 12 days after implantation, respectively.
Limitations of the study include its observational nature and the limited follow-up of 30 days, as well as the use of data from patients who attended high-volume tertiary TAVR centers, which may reduce the applicability of the findings to patients attending lower-volume centers.
On the basis of their findings, the researchers concluded that a “transcarotid approach could be considered as a safe alternative approach for TAVR when the transfemoral access is prohibited.”
Disclosures: The study was funded by Edwards Lifesciences. Please refer to original text for full list of author disclosures.
Overtchouk P, Folliguet T, Pinaud F, et al. Transcarotid approach for transcatheter aortic valve replacement with the sapien 3 prosthesis: A multicentre French registry. JACC Cardiovasc Interv [published online February 13, 2019]. doi: 10.1016/j.jcin.2018.11.014