Summary
Background
Transcarotid access is an alternative route for transcutaneous aortic valve implantation (TAVI) in patients with impossible transfemoral access.
Aims
We evaluated the safety, effectiveness and early and late clinical outcomes of CoreValve ® implantation via the common carotid artery.
Methods
Eighteen patients (10 men, 8 women; mean age 84 ± 5 years) at high surgical risk (mean EuroSCORE II 16 ± 13%) with significant peripheral artery disease underwent TAVI via common carotid artery access under general anaesthesia. Mean aortic valve area was 0.64 ± 0.13 cm 2 (0.36 ± 0.07 cm 2 /m 2 ).
Results
At a mean follow-up of 605 ± 352 days, two patients (11%) had died in hospital, on days 6 and 20, as a result of sepsis with multiorgan failure ( n = 1) or pneumonia ( n = 1). There were no perioperative deaths, myocardial infarctions or strokes. Perioperative prosthesis embolization occurred in one patient (6%), requiring implantation of a second valve. In-hospital complications occurred in four patients (23%): blood transfusion for transient significant bleeding at the access site in one patient (6%); permanent pacemaker implantation in two patients (11%); and pericardial drainage in one patient (6%). The rate of event-free in-hospital stay was 66%. Post-procedural echocardiography showed very good haemodynamic performance, with a mean gradient of 8 ± 3 mmHg. Moderate paravalvular leak was present in one patient (6%). Mean intensive care unit stay was 48 ± 31 h; mean in-hospital stay was 7 ± 3 days.
Conclusion
TAVI performed by transcarotid access in this small series of severely ill patients was associated with a low incidence of complications, which were associated with the procedure itself rather than the access route.
Résumé
Justification
l’abord transcarotidien est une alternative à la voie transfémorale pour la mise en place d’une prothèse valvulaire aortique par voie transcutanée (TAVI).
Objectif
nous avons évalué la sécurité, l’efficacité ainsi que les évènements à court et moyen termes après implantation d’une valve CoreValve, en utilisant la voie de l’artère carotide commune.
Méthode
18 patients, 10 hommes, 8 femmes, d’âge moyen 84 ± 5 ans, à haut risque chirurgical (EuroScore II moyen 16 ± 13) porteurs d’une artériopathie périphérique significative ont bénéficié d’un TAVI en utilisant la voie de l’artère carotide commune, sous anesthésie générale. La surface valvulaire aortique moyenne était de 0,64 ± 0,13 mc 2 (soit une surface aortique indexée à 0,36 ± 0,07 cm 2 /m 2 ).
Résultats
lors d’un suivi moyen de 605 ± 352 jours, deux patients (11%) sont décédés pendant la phase hospitalière à J6 et J20 du fait d’un sepsis lié à une défaillance multiviscérale (1 patient) et du fait d’une pneumonie (1 patient). Il n’y a pas eu de décès péri-opératoire, d’infarctus du myocarde ou d’accident ischémique cérébral. L’embolisation péri-opératoire de la prothèse a été observée chez un patient soit 6% nécessitant l’implantation d’une seconde valve. Les complications en phase hospitalière sont survenues chez 4 patients soit 23%.: transfusion globulaire pour un saignement transitoire au site d’accès chez un patient (6%), implantation permanente d’un pacemaker chez 2 patients (11%), et drainage péricardique chez un patient (6%). Le taux actuariel de survie sans évènement est de 66% lors de ce suivi évolutif de près de deux ans. L’échographie post-procédurale a montré la performance hémodynamique satisfaisante avec un gradient moyen post-procédural de 8 ± 3 mmHg. Une régurgitation paravalvulaire modérée a été décrite chez un seul patient (6%), le séjour moyen en soins intensifs au décours de l’intervention était de 48 ± 31 heures, et la durée de séjour hospitalier de 7 ± 3 jours.
Conclusion
le TAVI par voie carotide commune dans cette série préliminaire de patients porteurs de sténose aortique sévère avec des comorbidités majeures semble sûr avec une incidence faible de complications. Les complications sont dominées par celles liées à la procédure elle-même et ne sont pas liées à la voie carotidienne.
Background
TAVI has emerged as a current routine alternative procedure for treating severe aortic valve stenosis in patients who are inoperable and at high surgical risk . Transfemoral access is the most commonly used route . However, patients with limited vascular access caused by severe calcification or tortuosity, previous iliofemoral surgery, type B aortic dissection or surgically treated type A aortic dissections may not be candidates for transfemoral access. For these patients, the need for TAVI has led to the development of transapical, transaortic and transaxillary/transsubclavian alternatives. Generally, a patent left internal thoracic artery coronary bypass graft precludes left transsubclavian access because of the risk of coronary hypoperfusion by the 18 F delivery sheath positioned in the left subclavian artery. An implantable pacemaker/defibrillator in the subclavian region may also restrict transsubclavian access. Transapical or transaortic accesses both require thoracotomy or mini-sternotomy. Transcarotid access has been slowly gaining popularity as an alternative in the growing TAVI arena when other routes are not feasible. The purpose of our prospective study was to assess the feasibility and safety of transcarotid access for a specific group of patients.
Methods
Patient selection
Since November 2012, 18 consecutive patients (10 men and 8 women) with peripheral artery disease and severe symptomatic aortic stenosis underwent the TAVI procedure via transcarotid access. These patients were not eligible for cardiac surgery because of multiple co-morbidities and a high perioperative risk. Each patient was selected for TAVI after multidisciplinary heart team evaluation. All patients underwent routine preoperative coronary angiography, transthoracic echocardiography and contrast-enhanced cardiac computed tomography (CT). Transcarotid artery access was chosen when transfemoral access was not suitable because of severe peripheral arteriopathy, major tortuosity or previous iliofemoral surgery. The patency and anatomy of the carotid artery were evaluated preoperatively with contrast-enhanced CT. All patients had preoperative functional assessment of the carotid artery by transcranial Doppler examination.
Procedure
Procedures were performed by a multidisciplinary team that included anaesthesiologists, interventional cardiologists and cardiac surgeons, with patients under general anaesthesia and transoesophageal echocardiographic monitoring. Aspirin 100 mg/day was started the day before the procedure, without additional antiplatelet agents. Patients received 1.5 g of cefuroxime by intravenous injection immediately before the incision. All procedures except one were performed via the right common carotid artery (CCA). After intravenous injection of 5000 U of unfractionated heparin, a surgical cut-down of the right CCA was performed, and an 18 F sheath was inserted directly into the right CCA for introduction of the valve delivery system (CoreValve ® ReValving System; Medtronic, MN, USA). Cerebral oximetry monitoring was performed during the procedure, based on near infrared spectroscopy during the procedure to detect ischaemic cerebral complications. An aortic root pigtail catheter was advanced through a 5 F arterial sheath in the femoral artery for angiographic visualization. A temporary pacemaker lead was inserted via the femoral vein through a 6 F sheath. A stiff wire (Safari™ pre-shaped TAVI guidewire; Boston Scientific, Marlborough, MA, USA) was used for guiding the valve. No balloon aortic valvuloplasty was performed before TAVI implantation. After the valve was delivered, the sheath was retrieved, and the CCA was surgically purged and repaired with the aid of a 6-0 polypropylene suture. A drain was inserted, and the incision was closed ( Figs. 1 and 2 ). Patients were then transferred to the intensive care unit. Transthoracic echocardiography was used to assess the prosthetic valve function on day 1 and during follow-up at 1 and 6 months.