Aortic valve implantation using the femoral and apical access: a single center experience.

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Aortic valve implantation using the femoral and apical access: a single center experience. R. Hoffmann, K. Brehmer, R. Koos, R. Autschbach, N. Marx, G. Dohmen Rainer Hoffmann, University Aachen, Germany ESC 2010

Disclosure of interest: Nothing to disclose

Background Transcatheter aortic valve implantation (TAVI) is a new treatment option for poor surgical candidates with symptomatic aortic stenosis. Femoral as well as apical access sites are used for the procedure. The joint application of both techniques in clinical practice has not been well evaluated.

Aim To evaluate the use of femoral as well as apical access site transcatheter aortic valve implantation in a single center experience.

Patients 134 high-risk surgical candidates or inoperable patients underwent TAVI. 70 patients were treated from the apical access using an Edwards SAPIEN valve and 64 patients were treated from the femoral access using the CoreValveTM. Transesophageal echocardiography, computed tomography prior to intervention in all patients to define aortic root dimensions.

Transapical and Transfemoral Access TAVI Transapical Access TAVI Apical access site TAVI was performed with general anesthesia Edwards Sapiens prosthesis was performed after valvuloplasty using the provided balloon. Transfemoral Access TAVI Transfemoral access site TAVI was performed under general anesthesia in 5 patients and with local anesthesia in 59 patients. Balloon valvuloplasty with 20 or 22 mm Nucleus balloon prior to Corevalve prosthesis of 26 mm and 22 or 25 mm Nucleus balloon prior to 29 mm prosthesis. Closure of access site using one Prostar device.

Choice of Access Site Reasons favoring apical access site approach included peripheral artery disease, severe calcification of the aortic root, annulus diameter < 20 mm. Reasons favoring femoral access site approach included very old age (>85 years), lung disease, annulus diameter 25-27 mm. Choice of access site was determined in a joint cardiology cardiac surgery session.

Postinterventional Care 48 hours on monitoring ward unless patient had pacemaker before procedure or obtained pacemaker immediately after the procedure. >5 days of monitoring in hospital in case of implanted pacemaker and >7 days of monitoring in hospital in patients without implanted pacemaker. 30 day outpatient or telephone contact.

Analysis of Predictors of Mortality Age, Gender, LV-Function, renal insufficiency, prior cardiac surgery, pulmonary hypertension, coronary artery disease, EuroScore, ejection fraction, Agaston Score of aortic valve, choice of TAVI access were included in the analysis.

Baseline Clinical Characteristics Transapical access (n= 70) Transfemoral access (n=64) Age, years 78 ± 7 84 ± 6 Male, n (%) 29 (42) 15 (24) Previous cardiac surgery, n (%) 16 (22) 5 (8) Renal insufficiency, n (%) 39 (56) 30 (47) Pulmonary hypertension, n (%) 12 (17) 17 (27) Coronary artery disease, n (%) 46 (66) 41 (64) NHYA class 3.2 2.9 EuroScore 30 28

Preprocedural Aortic Characteristics Transapical access (n= 70) Transfemoral access (n=64) Mean gradient, mmhg 45 ± 16 51 ± 17 Aortic valve area, cm 2 0.58 ± 0.16 0.72 ± 0.19 Annular diameter, mm 22.0 ± 2.7 22.5 ± 2.6 Agaston score 2213 ± 1216 2236 ± 1393 Left ventricular ejection fraction <35%, n (%) 8 (11) 3 (5)

Procedural Characteristics Transapical access (n= 70) Transfemoral access (n=64) CoreValve 26 mm device 36 (56) CoreValve 29 mm device 28 (44) Edwards Sapiens 23 mm 20 (29) Edwards Sapiens 26 mm 50 (71)

Clinical Events During 30 Day Follow-up Transapical access (n= 70) Transfemoral access (n=64) All cause death, n (%) 7 (10) 8 (13) Procedural death (%) 2 (3) 2 (3) Stroke, n (%) 0 (0) 2 (2) Pacemaker implantation, n (%) 2 (3) 19 (29)

Predictors of 30 Day Mortality Agaston score of the aortic valve was the only independent predictor of 30 day mortality (OR=1.009 per additional score point; p=0.009).

Limitations No randomized study Single center study Limited patient number Inclusion of all run-in patients within apical as well as femoral access groups

Conclusions In this single center experience with balanced use of femoral and apical access TAVI, patients treated from the femoral access site were older than the apical access site patients. The slightly higher 30 day mortality in the femoral access TAVI group may be attributable to the higher patient age. Greater valvular calcification was associated with higher mortality.