Summary
Background
The first French transapical transcatheter aortic valve implantation (TAVI) was performed in July 2007 in our department.
Aims
To report 4-year outcomes of transapical implantation with the Edwards transcatheter bioprosthesis.
Methods
We prospectively evaluated consecutive patients who underwent transapical implantation with an Edwards transcatheter bioprosthesis between July 2007 and October 2011. Patients were not suitable for conventional surgery (due to severe comorbidities) or transfemoral implantation (due to poor femoral access).
Results
Among 61 patients (59.0% men), mean logistic EuroSCORE was 27.5 ± 14.9% and mean age was 81.0 ± 6.8 years. Successful valve implantation was achieved in 59/61 patients (96.7%) of patients. The other two patients required conversion to conventional surgery due to prosthesis embolization and died. Six additional patients died in the postoperative period. Causes of perioperative death were two septic shocks (one of peritonitis), two multi-organ failure, one ventricular fibrillation and one respiratory insufficiency. Intraprocedural stroke was not observed in any patient. The actuarial survival rates at 1, 2 and 4 years were 73.8%, 67.2% and 41.0%. During this 4-year period, four patients died of cardiovascular events, but no impairment of transprosthesis gradient was observed.
Conclusion
Our series of 61 patients who underwent transapical implantation of the Edwards transcatheter bioprosthesis shows satisfactory results, similar to other reports, considering the high level of severity of patients referred for this method. Transapical access is a reliable alternative method for patients that cannot benefit from a transfemoral approach.
Résumé
Contexte
La première implantation française d’une valve aortique transcathéter (TAVI) a été réalisée dans notre service en juillet 2007.
Objectif
Nous rapportons le suivi pendant quatre années de nos implantations transapicales avec la bioprothèse Edwards transcathéter.
Méthodes
De juillet 2007 à octobre 2011, nous avons évalué prospectivement 61 patients consécutifs (EuroSCORE logistique : 27,5 ± 14,9 %). Leur âge moyen était de 81,0 ± 6,8 ans et 59,0 % étaient des hommes. Tous ces patients ont bénéficié d’une implantation transapicale de la bioprothèse Edwards transcathéter. Tous ces patients avaient été récusés pour la chirurgie conventionnelle en raison de comorbidités sévères et n’étaient pas éligibles pour une implantation transfémorale à cause de mauvais axes iliofémoraux.
Résultats
L’implantation de la valve a été réalisée avec succès chez 96,7 % des patients. Deux patients ont nécessité une conversion en chirurgie conventionnelle à cause de la migration de la valve et sont morts. Six autres patients sont morts dans la période postopératoire. Les causes de décès periopératoires ont été : deux chocs septiques dont un avec péritonite, deux défaillances multiviscérales, une fibrillation ventriculaire et une insuffisance respiratoire. Aucun accident vasculaire cérébral per procédure n’a été observé chez aucun patient. Le taux de survie actuarielle à un, deux et quatre ans a été respectivement de 73,8 %, 67,2 % et 41,0 %. Durant cette période de quatre ans, quatre patients sont décédés de causes cardiovasculaires. Aucune dégradation du gradient transprothétique n’a été observée durant cette même période.
Conclusions
Notre série de 61 implantations de la bioprothèse transcathéter Edwards montre des résultats satisfaisants et comparables à la littérature, considérant le niveau élevé de gravité des patients proposés pour cette technique. La voie transapicale est une méthode alternative fiable pour les patients ne pouvant bénéficier de la voie transfémorale.
Background
In April 2002, the first human percutaneous aortic valve implantation was performed in Rouen . Different approaches quickly became feasible and, despite the historical use of the antegrade transseptal approach, the retrograde approach became popular during 2005, with the development of the RetroFlex catheter . Due to the large diameter of the first models of the RetroFlex catheter (22/24 F) and the presence, in numerous patients, of small-calibre vessels or vascular disease, the idea of a transapical approach emerged. In 2005, after an animal feasibility study , the first patients were implanted via a small anterolateral mini thoracotomy . In July 2007, the first transapical implantation in France was performed in our department. Since this time, 61 patients have been implanted using this approach. We report the 4-year outcomes of these patients.
Methods
Between July 2007 and October 2011, 61 patients have been implanted using a transapical approach. A transfemoral approach was not appropriate in these patients due to small-calibre vessels, vascular disease or porcelain aorta. These consecutive patients were included in a prospective, single-centre registry. All patients selected by our multidisciplinary team had severe, degenerative aortic stenosis, and were included according to the inclusion criteria of successive European trials and registries (Partner, Source, France2). All patients gave written informed consent.
The screening process included transthoracic echocardiography (TTE) in all patients. An annulus diameter of 18–21 mm was considered appropriate for the 23 mm prosthesis and more than 21–24.5 mm for the 26 mm prosthesis. Selective coronary angiography, aortoiliac angiography and computed tomographic iliofemoral angiography were systematically performed. Patients with an iliofemoral diameter less than 7 or less than 8 mm (for the 23 or 26 mm SAPIEN valves, respectively) or 6 or 6.5 mm (for the 23 or 26 mm SAPIEN XT valves, respectively) led to the transapical approach.
Patients and procedure
From July 2007 to September 2010, the procedures were performed using a SAPIEN valve and an Ascendra 1 delivery system. This valve was made of three bovine pericardial leaflets sewn onto a stainless steel stent frame partially covered with a synthetic polyethylene terephthalate (PET) fabric sealing cuff. Thereafter, the procedures were performed using an Ascendra 2 delivery system with a 22 F internal diameter sheath and a SAPIEN XT valve. This valve uses a cobalt chromium frame.
All procedures were performed under general anaesthesia in a conventional cardiac surgery operating theatre using a mobile imaging system GE OEC 9900 C-arm.
Before the surgical procedure, a TTE apical four-chamber view was performed by the surgeon to check the best access to the apex of the left ventricle. Depending on the result, a small (6–8 cm) anterolateral thoracotomy was performed in the fourth or fifth intercostal space. Two concentric purse strings using 2/0 Prolene were achieved, close to the apex, on the lateral wall of the left ventricle. After ventricular puncture, a 0.035 inch Amplatz Extra-Stiff J-tip guide wire (COOK, Bjaeverskov, Denmark) was placed through the native aortic valve into the descending aorta. In the first part of the procedure, a valvuloplasty using a 20 mm balloon (Edwards, Irvine, CA, USA) was performed under rapid ventricular pacing (180–220 bpm) using a temporary endocardial right ventricle pacing lead introduced through the femoral vein. The Ascendra delivery system sheath was introduced carefully under fluoroscopic control and the depth of the device was measured using radiopaque markers. Valve positioning was based on fluoroscopy using annular calcification as a landmark. The prosthesis was delivered using rapid ventricular pacing. Removal of the sheath was achieved cautiously by gently tightening the two concentric purse strings using no rapid pacing. The pacing lead was removed at the end of the procedure.
Data collection
Clinical and TTE parameters were obtained at baseline, discharge and 1, 2, 3 and 4 years, and the data were entered into our institutional database.
Statistical analysis
Qualitative variables are expressed as counts and percentages; and quantitative variables as mean ± standard deviation (SD). All data were analysed using SPSS software (v17).
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