Vascular Complications of Transfemoral Edwards SAPIEN Aortic Valve Implantation
- Volume 9 - Issue 12 - December 2012
- Posted on: 12/3/12
- 0 Comments
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Rodrigo Estévez-Loureiro, MD, Jorge Salgado-Fernández, MD, Nicolás Vázquez-González, MD, Ramón Calviño-Santos, MD, Oscar Prada-Delgado, MD, María Rita Soler-Martín, PhD, Antonio Toral-Pérez, MD, María José Martínez-Sapiña-Llanas, MD, Xacobe Flores-Ríos, PhD, Guillermo Aldama-López, MD, Pablo Piñón-Esteban, MD, José J. Cuenca-Castillo, MD, Alfonso Castro-Beiras, PhD
From Complejo Hospitalario Universitario A Coruña, Spain.
ABSTRACT: Background: Transcatheter aortic valve implantation has recently emerged as an alternative treatment for patients with severe aortic stenosis who have been rejected for conventional aortic valve replacement due to high surgical risk. The aim of this study is to describe vascular access site complications observed in a cohort of patients who underwent transfemoral aortic valve implantation using the Edwards SAPIEN device in a single center.Methods: Prospective single-center analysis of vascular complications that occurred during transfemoral implantation of the Edwards SAPIEN aortic valve prosthesis. Results: Between November 2008 and May 2011, 56 patients underwent transfemoral aortic valve implantation. Vascular complications were observed in 13 patients, including major complications in 5 patients (8.9%) and minor complications in 8 patients (14.3%). Major vascular complications were associated with age (87.2±3.5 vs 82.9±4.4 years; P=.038), female sex (100% vs 52.9%; P=.042), left femoral artery access (60% vs 9.8%; P=.017), and body surface area (1.1±0.13 vs 1.2±0.2 m2; P=0.027). Vascular complications were not associated with mortality, although a nonsignificant increase of in-hospital stay was observed in patients who developed vascular complications (8.6±5.9 vs 5.2±2.6 days; P=.254). Conclusions: Vascular complications are common during transfemoral aortic valve implantation, although they are not associated with higher mortality.
VASCULAR DISEASE MANAGEMENT 2012:9(12):E209-E216
Key words: aortic stenosis, transfemoral aortic prosthesis, vascular complications
Aortic stenosis is a symptomatic valvulopathy with a higher prevalence in Western countries.1 When this condition is associated with cardiovascular symptoms such as angina, heart failure, or syncope of unknown etiology, valve replacement is considered the first-line treatment.2 It occurs predominantly in elderly patients in association with other comorbidities3 who, due to the higher surgical risk,4 are not good candidates for surgical valve replacement. In recent years, transcatheter aortic prosthesis implantation has emerged as a safe and efficient alternative in patients rejected for cardiac surgery.
Several series of patients have been recently published showing acceptable results at the short and long term with either of the two devices approved to date: Edwards SAPIEN aortic valve prosthesis (Edwards Lifesciences) and CoreValve Revalving System (Medtronic).5-8
Moreover, it has been demonstrated that in this group of high-risk patients the use of the Edwards prosthesis is not inferior to conventional surgery.9 However, in spite of continuous improvements, the size of these devices remains large, and the development of vascular complications associated to the transfemoral access site and its relation with adverse events remains a matter of concern.10
The objective of the present study was to determine the incidence of vascular complications and their effect in the short- and long-term prognosis of a cohort of patients who underwent transfemoral implantation of the Edwards SAPIEN prosthesis (ES prosthesis).
Patients and methods
Patients with severe aortic stenosis and high surgical risk were evaluated in a specialized unit. The final decision on treatment was made by a multidisciplinary team of interventional cardiologists, cardiac surgeons, and clinical cardiologists. Transthoracic echocardiogram with aortic annulus measurement, cardiac catheterization with angiography, and computed axial tomography (CT) of the aortic and iliofemoral axes were performed in all patients.
Angiography was performed in the same procedure as coronary angiography and valvular hemodynamic study. Aortograms were performed with an injection of contrast media in the aortic root and in the descending thoracic aorta, with concomitant angiography of the iliofemoral axes up to the femoral bifurcation. Images were stored in a DICOM format and analyzed to determine the extent of arterial tortuosity and minimal diameter of the artery (Philips Xcelera System for vascular analysis).