The Sapien 3 device (Edwards Lifesciences) can be safely and effectively used in transcatheter aortic valve implantation (TAVI) via the transcarotid approach in patients for whom the transfemoral route is not suitable, according to 30-day results from a multicentre French registry. The authors of the study, published in the JACC: Cardiovascular Interventions, say: “This descriptive study reports the largest contemporary cohort to date of transcarotid TAVI and demonstrates the safety and efficacy of the transcarotid approach for TAVI with the Edwards Sapien 3 transcatheter heart valve.”
Transfemoral access is the favoured route for TAVI. Although there have been suggestions of a possible role for transcarotid access in patients for whom this approach is precluded, there is very little data on the safety and efficacy of Sapien 3.
The French Transcarotid TAVI registry is a collaborative initiative developed by interventional cardiologists and cardiac surgeons performing transcarotid TAVI. Patient data, including demographics, clinical and procedural characteristics, and outcomes, were prospectively collected between January 2014 and April 2018 from 13 participating centres. Patients with severe symptomatic aortic stenosis estimated to be at high surgical risk were considered for TAVI, and multimodal vascular imaging was performed to determine the possible approaches. When patient anatomy ruled out transfemoral access, a non-femoral route was considered.
Overall, 6,680 patients underwent TAVI at the 13 centres; 314 patients were treated with the Sapien 3 transcatheter heart valve through the transcarotid approach and included in the study. Median age was 83 years old, and 63% were male. One-third of participants had atrial fibrillation, two-thirds had moderate to severe chronic renal failure, and 64% had peripheral arterial disease.
In 91% of patients, transcarotid TAVI was performed under general anaesthesia, and in 73.6% of cases, access was via the left carotid artery. The procedural success rate was 97%. Three annulus ruptures were reported, all of which led to patient death. At 30 days, the rate of major bleeding was 4.1%, new permanent pacemaker 16%, and rate of stroke or transient ischaemic attack was 1.6%. The 30-day mortality rate was 3.2%, and median hospital stay was seven days.
Pavel Overtchouk, Thomas Modine (both Lille University Hospital, Lille, France) and others acknowledge the limitations of the study, which included possible bias, as “only patients treated with the Sapien 3 device were included”. Additionally, they say: “Outcomes of this study represent those of tertiary high-volume TAVI centres familiar with the transcarotid approach, thus should be interpreted with caution. Registry data can also be subject to under reporting of complication rates.” And, because follow-up was for 30 days only, they propose that “more extended follow-up might provide further insight regarding long-term outcomes”. They also call for further studies to assess the suitability of other access routes, such as transsubclavian, transapical, and transaortic, and for more extensive data on the safety of transcarotid TAVI in low-risk patients and all-comers to “allow operators to consider this approach regardless of the risk profile”.
The observation of two conversions to open surgery in the registry, attributed to excessively tortuous carotid anatomy, led the Overtchouk and Modine et al to recommend that “excessive tortuosity of the carotid artery should be considered as a contraindication to the transcarotid approach”, and that “the transcarotid access should only be attempted after careful evaluation of its feasibility on preoperative MSCT [multi-slice computed tomography]”.
They describe the 30-day mortality rate as “acceptable” and “lower than previous observational reports with the transcarotid access in higher risk patients (6% to 7%)”. Stroke and transient ischaemic attack are a major concern when using the transcarotid route, and the researchers suggest the low rate could have been due to the preoperative evaluation, which may have selected patients at lower risk of cerebrovascular events.
Overtchouk and Modine et al propose that a transcarotid approach could become the first-line alternative for TAVI in selected patients where transfemoral access is prohibited: “The Sapien 3 device was safe and effective in our multicentre cohort. The transcarotid approach could be considered as a safe alternative approach for TAVI.”