• Valvular Disease
• Imaging Modalities
• Cardiology
• Cardiology Clinical Trials
• Interventional Techniques & Devices

Transcatheter aortic valve implantation (TAVI) is a viable treatment option for high-risk surgical patients with severe symptomatic aortic stenosis (AS). The SAPIEN XT™ (SXT) and CoreValve® with AccuTrak™ delivery system (MCVAT) are new generation devices currently available in Europe for transfemoral TAVI. To date, no prospective comparisons between these 2 devices have been undertaken. The objectives of this study, presented by Alaide Chieffo, MD, San Raffaele Scientific Institute, Milan, Italy, were to assess the overall clinical outcomes of TAVI and to compare the SXT versus MCVAT devices in a nonrandomized registry population.

Patients enrolled in the Milan Registry (n=400) were evaluated with echocardiography to assess severity of AS, annulus size, and left ventricular ejection fraction (LVEF) and multislice computed tomography scan with echocardiogram-gating and contrast injection to evaluate the coronary arteries, annulus size, aorta, and the iliac and femoral arteries. The registry included patients treated with TAVI using either the SXT (n=144) or MCVAT (n=119) devices. Transfemoral access was the route of choice unless contraindicated.

The overall mean age was 79.4±7.4 years. The 30-day event rates in the overall population (n=400) using the Valve Academic Research Consortium definition were as follows: all-cause mortality (4.7%), cardiovascular (CV) mortality (3.6%), myocardial infarction (MI; 1.3%), stroke (1.0%), life-threatening bleeding (22.7%), major vascular complications (13.5%), and acute kidney injury (AKI) stage 3 (9.6%). The success rate for device delivery was 92.5%.

Analysis according to valve type showed important differences in baseline characteristic between patients receiving the SXT (n=132) versus the MCVAT (n=89), including the percentage of males (41.7% vs 58.4%; p=0.014), LVEF (54.5±11.3 vs 48.0±15.5; p<0.001), history of cerebrovascular disease (12.9% vs 3.4%; p=0.017), previous coronary artery bypass graft surgery (12.9% vs 26.1%; p=0.013), Society of Thoracic Surgeons score (7.4±6.5 vs 9.9±10.2; p=0.030), and aortic annulus diameter (23.3±1.8 vs 24.4±2.0; p<0.001). There was no significant difference between the 2 device groups in the rates of all-cause mortality, CV mortality, MI, stroke, life-threatening bleeding, AKI stage 3, major vascular complications, combined safety endpoint, combined efficacy endpoint, and moderate to severe prosthetic aortic regurgitation.

There were, however, significant differences between the SXT and MCVAT groups in the rates of valve embolization (0% vs 9.0%; p<0.001), need for 2 valves (1.5% vs 7.9%; p=0.021), conduction disturbances and arrhythmia (16.9% vs 36.0%; p=0.001), permanent pacemaker implantation (5.4% vs 32.6%; p<0.001), and device success (97.0% vs 89.9%; p=0.028; Table 1), favoring the patients treated with an SXT valve.

Prof. Chieffo concluded that TAVI is a viable option for patients at high risk for surgical aortic valve replacement in her center using both the SXT and MCVAT via a range of access routes.

• © 2012 MD Conference Express®