Transcarotid access works for transcatheter aortic valve replacement (TAVR) with the Sapien 3 device despite the arteries' proximity to the brain, a French registry study showed.
Patients had no notable excesses in major bleeding (4.1%), major vascular complications (1.6%), tamponade (1%), perioperative coronary obstructions (0.6%), moderate-to-severe paravalvular leaks (5.1%), and stroke or transient ischemic attack (1.6%) at 30 days, reported Thomas Modine, MD, PhD, MBA, of the Centre Hospitalier Régional Universitaire de Lille in France, and colleagues.
The 30-day mortality rate was just 3.2%. There were, however, three fatal annulus ruptures during the procedure and new permanent pacemakers were required in 16.2% overall, according to the study in JACC: Cardiovascular Interventions.
Modine's group called the transcarotid approach "safe and effective" based on these data. "The transcarotid approach might be considered, in selected patients, as the first-line alternative approach for TAVR whenever the transfemoral access is prohibited."
In the study were 314 consecutive transcarotid TAVR patients deemed anatomically unsuitable for transfemoral access. Before the procedure, they had undergone multi-slice CT, Doppler ultrasound, and cerebral MRI to confirm no severe stenosis or occlusion of the contralateral carotid or vertebral arteries.
Investigators noted that the 4.1% rate of major bleeding is lower than what has been reported for transfemoral TAVR with the Sapien 3 (rates in the low-to-mid teens, according to one study cited by the group). Moreover, the low stroke rate here is lower than the 5.5% achieved in the PARTNER 2 trial in which patients largely got transfemoral access, they said.
"The group led by Dr. Modine has gone a long way to showing us that transcarotid access does not have the feared neurologic consequences and may well also be equivalent to subclavian and transfemoral access," commented Michael Reardon, MD, and Colin Barker, MD, both of Houston Methodist Hospital, in an accompanying editorial.
The 3.2% mortality rate is also "very respectable," the duo said. They agreed that transcarotid TAVR with the Sapien 3 is "safe and effective" and noted similar results with the Evolut valve.
Study participants were recorded in the French registry as having received transcarotid TAVR in 2014-2018 at one of 13 high-volume centers. Procedural success reached 97%. General anesthesia had been used in 91% of cases; operators preferred the left carotid artery for access (73.6%).
Median age was 83 and 63% were men. The group generally had intermediate to high surgical risk (Society of Thoracic Surgeons mortality risk, 5.8%). Two-thirds were classified into the New York Heart Association functional class III or IV, and another two-thirds had peripheral artery disease.
"Whether this is your first choice if transfemoral is not available will be for each TAVR team to decide. We do believe however that the concept of 'alternative access' needs to be reconsidered in light of the pioneering work of Dr. Modine and others," Reardon and Barker said.
"We believe that transfemoral access should be considered the 'standard' and that any other routes that can show the safety, efficacy and recovery similar to transfemoral access should also be considered standard and not alternative access. Other non-chest wall penetrating access may also eventually achieve results similar to transfemoral once enough experience and data are acquired and that access will eventually be divided into transthoracic and non-transthoracic," according to the editorialists.
It remains to be seen if the favorable outcomes of transcarotid TAVR will hold up in the long-term or if the results are generalizable to other centers. Additionally, Modine's group acknowledged the potential for selection bias in their observational study.
The study was funded by Edwards Lifesciences.
Modine disclosed relevant relationships with Boston Scientific, Medtronic, Edwards, Cephea, MicroPort, GE, and Abbott, as well as support from Edwards.
Reardon and Barker disclosed no relevant relationships with industry.
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