Author + information
- Received October 22, 2018
- Revision received November 9, 2018
- Accepted November 13, 2018
- Published online February 13, 2019.
- Pavel Overtchouk, MDa,
- Thierry Folliguet, MD, PhDb,
- Frédéric Pinaud, MD, PhDc,
- Oliver Fouquet, MDc,
- Mathieu Pernot, MDd,
- Guillaume Bonnet, MDd,
- Maxime Hubert, MDe,
- Joël Lapeze, MDf,
- Jean Philippe Claudel, MDf,
- Said Ghostine, MDg,
- Alexandre Azmoun, MDg,
- Christophe Caussin, MDh,
- Konstantinos Zannis, MDh,
- Majid Harmouche, MDi,
- Jean-Philippe Verhoye, MD, PhDi,
- Antoine Lafont, MD, PhDj,
- Chekrallah Chamandi, MDj,
- Vito Giovanni Ruggieri, MD, PhDk,
- Alessandro Di Cesare, MDk,
- Florence Leclercq, MD, PhDl,
- Thomas Gandet, MDl and
- Thomas Modine, MDa,∗ ()
- aLille University Hospital, Lille, France
- bHenri Mondor Hospital, Créteil, France
- cAngers University Hospital, Angers, France
- dBordeaux University Hospital, Pessac, France
- eBrabois University Hospital, Vandoeuvre les Nancy, France
- fInfirmerie Protestante, Lyon, France
- gMarie Lannelongue Hospital, Plessis-Robinson, France
- hInstitut Mutualiste Montsouris, Paris, France
- iRennes University Hospital, Rennes, France
- jHôpital Européen Georges Pompidou, Paris, France
- kRobert Debré University Hospital, Reims, France
- lMontpellier University Hospital, Montpellier, France
- ↵∗Address for correspondence:
Dr. Thomas Modine, Department of Cardiology and Cardiovascular Surgery, Institut Coeur Poumon, Centre Hospitalier Régional Universitaire de Lille (CHRU de Lille), 2 Avenue Oscar Lambret, 59037 Lille, France.
Objectives 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.
Background 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.
Methods 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).
Results A total of 314 patients were included with a median (interquartile range) age of 83 (78 to 88) years old, 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%.
Conclusions 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.
The study was funded by Edwards Lifesciences. Dr. Folliguet is a consultant for Sorin/LivaNova. Dr. Caussin is a proctor for Medtronic and Edwards Lifesciences. Dr. Lafont is cofounder of Arterial Remodeling Technologies. Dr. Ruggieri has received consulting fees from Vascutek Terumo. Dr. Modine is a consultant for Boston Scientific, Medtronic, Edwards, Cephea, Microport, GE, and Abbott; and has received a research support grant from Edwards. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received October 22, 2018.
- Revision received November 9, 2018.
- Accepted November 13, 2018.
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