Abstract

Abstract Objectives The transcarotid (TC) approach for transcatheter aortic valve implantation (TC-TAVI) is potentially an optimal alternative to the gold standard, transfemoral approach. Unfortunately, few studies are reported regarding the safety and efficacy of TC-TAVI. Methods Using data from the national prospective French registry in France - the FRANCE TAVI registry – included a total of 12804 patients entered in the dataset between January 2013 and December 2015. Patients who underwent TF-TAVI or TC-TAVI were 11033 (10598 and 435 respectively) and represented our study cohort. The primary endpoints were perioperative all-cause mortality (either in-hospital mortality or 30-day mortality) and in-hospital complications (annulus rupture, aortic dissection, valve migration, cardiac tamponade, stroke, STEMI, permanent pacemaker implantation, pulmonary embolism, renal failure, renal dialysis). All-cause mortality at follow-up was a secondary endpoint of the study. Results Among 11033 patients included in the current study 10598 (96%) underwent a femoral TAVI, and 435 (4.1%) a TC-TAVI. Patients in the TC-TAVI access group presented with a higher risk profile (mean logistic EuroSCORE1 8.2 vs. 20.3, P<0.001), with a higher rate of peripheral vascular disease, known coronary artery disease, chronic pulmonary disease and renal failure, dialysis and urgent status of TAVI. Four hundred and nineteen patients (3.8%) died during in-hospital stay, with no differences between the two groups (p-value 0.73). TC-TAVI had higher postoperative incidence of stroke (4.4% vs 1.9%, chi-square p-value 0.001), ST elevated myocardial infarction (STEMI) (0.7% vs 0.2%, chi-square p-value 0.05), permanent pacemaker implantation (18.9% vs 15.2%, chi-square p-value 0.04), infections (6.7% vs 4.0%, chi-square p-value 0.01), bleeding (9.2% vs 4.7%, chi-square p-value <0.001), renal failure (5.1% vs 3.3%, chi-square p-value 0.06) and dialysis (5.1% vs 3.1%, chi-square p-value 0.03). Conversely, TF-TAVI was likely to have vascular complications (7.7% vs 3.2%, <0.001) There was no difference in short or midterm mortality rates. The Kaplan-Meier estimates of survival at 1 and 2 years were respectively 85.8%±0.4%, and 75.8%±0.6%. Conclusion Compared to femoral peripheral TAVI, TC-TAVI is safe, and associated with similar outcome except for a higher postoperative incidence of stroke and a twice-lower rate of access site-related complications. It should be considered in case of non-femoral peripheral access as the second access choice, to increase the overall safety of TAVI procedures.

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