Transcarotid Approach for Transcatheter Aortic Valve Replacement With the Sapien 3 Prosthesis

• Published in: JACC. Cardiovascular interventions 2019-03, Vol.12 (5), p.413-419
• Main Authors: Overtchouk, Pavel, Folliguet, Thierry, Pinaud, Frédéric, Fouquet, Oliver, Pernot, Mathieu, Bonnet, Guillaume, Hubert, Maxime, Lapeze, Joël, Claudel, Jean Philippe, Ghostine, Said, Azmoun, Alexandre, Caussin, Christophe, Zannis, Konstantinos, Harmouche, Majid, Verhoye, Jean-Philippe, Lafont, Antoine, Chamandi, Chekrallah, Ruggieri, Vito Giovanni, Di Cesare, Alessandro, Leclercq, Florence, Gandet, Thomas, Modine, Thomas
• Format: Article
• Language: English
• Subjects: Aortic Valve Stenosis/surgery; Cardiology and cardiovascular system; Carotid Arteries; Catheterization Peripheral/adverse effects; Heart Valve Prosthesis; Human health and pathology; Life Sciences; Sapien 3; TAVR; transcarotid
• ISSN: 1936-8798; 1876-7605
• DOI: 10.1016/j.jcin.2018.11.014

This study sought to describe the procedural and clinical outcomes of patients undergoing transcarotid (TC) transcatheter aortic valve replacement (TAVR) with the Edwards Sapien 3 device. The TC approach for TAVR holds the potential to become the optimal alternative to the transfemoral gold standard. Limited data exist regarding safety and efficacy of TC-TAVR using the Edwards Sapien 3 device. The French Transcarotid TAVR prospective multicenter registry included patients between 2014 and 2018. Consecutive patients treated in 1 of the 13 participating centers ineligible for transfemoral TAVR were screened for TC-TAVR. Clinical and echocardiographic data were prospectively collected. Perioperative and 30-day outcomes were reported according to the updated Valve Academic Research Consortium (VARC-2). A total of 314 patients were included with a median (interquartile range) age of 83 (78 to 88) years, 63% were males, Society of Thoracic Surgeons mortality risk score 5.8% (4% to 8.3%). Most patients presented with peripheral artery disease (64%). TC-TAVR was performed under general anesthesia in 91% of cases, mostly using the left carotid artery (73.6%) with a procedural success of 97%. Three annulus ruptures were reported, all resulting in patient death. At 30 days, rates of major bleeding, new permanent pacemaker, and stroke or transient ischemic attack were 4.1%, 16%, and 1.6%, respectively. The 30-day mortality was 3.2%. TC-TAVR using the Edwards Sapien 3 device was safe and effective in this prospective multicenter registry. The TC approach might be considered, in selected patients, as the first-line alternative approach for TAVR whenever the transfemoral access is prohibited. Sapien 3 device was safe and effective in our multicenter cohort. [Display omitted]