MD Conference Express ESC 2012 - (Page 9)
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TAVI: 10 Years after the First Case
Written by Toni Rizzo
Lessons from Clinical Trials The first human transcatheter aortic valve implantation (TAVI) was performed in 2002. Since then, TAVI has been evaluated as an alternative to surgical aortic valve replacement (SAVR) and medical treatment (MT) in several clinical trials. Steven Windecker, MD, Bern University Hospital, Bern, Switzerland, reviewed the evidence from these trials. The Placement of Aortic Transcatheter Valve [PARTNER] B trial, assessed TAVI versus MT in inoperable patients with symptomatic aortic stenosis (AS) [Leon MB et al. N Engl J Med 2010; Makkar RR et al. N Engl J Med 2012]. TAVI versus standard treatment (including balloon aortic valvuloplasty) resulted in lower rates of all-cause death (43.3% vs 68.0%; HR, 0.56; 95% CI, 0.43% to 0.73%; p<0.001) and cardiac death (31.0% vs 62.4%; HR, 0.44; 95% CI, 0.32% to 0.60%; p<0.001) at 2 years. Cerebrovascular event rates were 13.8% with TAVI versus 5.5% with MT (HR, 2.79; 95% CI, 1.25% to 6.22%; p=0.01). The rate and severity of paravalvular aortic regurgitation (AR) with TAVI decreased from 30 days to 2 years after implantation (p=0.001), while transvalvular AR rates did not change significantly (p=0.75). Mortality rates were higher in patients with AR (p<0.01). In the PARTNER A trial of TAVI versus SAVR in high-risk patients with symptomatic AS, all-cause death rates were similar after at least 2 years follow-up (HR, 0.90; 95% CI, 0.71% to 1.15%; p=0.41) [Smith CR et al. N Engl J Med 2011; Kodali SK et al. N Engl J Med 2012]. Stroke rates were 7.7% with TAVI versus 4.9% with SAVR (HR, 1.22; 95% CI, 0.67% to 2.23%; p=0.52), as was paravalvular regurgitation (p<0.001). After 2 years, aortic valve area and mean aortic gradient were similar in the TAVI and SAVR groups (p=0.16 for both). During the past decade, clinical trials have shown that TAVI is superior to standard treatment and non-inferior compared with SAVR. However, stroke is an issue early after TAVI. Valve durability appears to be maintained beyond 2 years of follow-up, but the impact of AR on outcomes needs to be improved. TAVI effectively alleviates symptoms and improves health-related quality of life (QoL) compared with standard medical therapy. Low- and High-Risk Patients: What Are the Limits? Bernard Prendergast, DM, John Radcliffe Hospital, Oxford, United Kingdom, discussed patient selection for TAVI. He reviewed current tools for risk stratification and the risks of TAVI in low- and high-risk patients.
The PARTNER trial had strict entry criteria, requiring 2 cardiac surgeons and an interventionist to attest that candidates were not suitable for SAVR (high surgical risk due to coexisting conditions associated with mortality risk of at least 15% by 30 days after surgery [Society of Thoracic Surgeons (STS) score ≥10%]) [Leon MB et al. N Engl J Med 2010]. In a registry of 3195 high-risk TAVI patients, 835 (26%) had a European System for Cardiac Operative Risk Evaluation (EuroSCORE) <20% and an STS score <10% but had contraindications to surgery [Gilard M et al. N Engl J Med 2012]. Lange et al. [J Am Coll Cardiol 2012] reported that clinical outcomes were significantly better in lowerversus higher-risk patients undergoing TAVI in a single center from 2007 to 2010. In another observational study, patients allocated to SAVR were younger and had lower predicted perioperative risk than patients allocated to MT or TAVI [Wenaweser P et al. J Am Coll Cardiol 2011]. At 30 months, mortality was lower with SAVR (22.4%) and TAVI (22.6%) compared with MT (61.5%; p<0.001). According to Kovac et al. [Heart 2010], the EuroSCORE and STS scores have not been well validated in estimating risk for valve-only surgery; some TAVI-specific measures are not considered, and social and QoL issues are not included. Van Brabandt et al. [BMJ 2012] claimed that TAVI is risky and costly, with rapid expansion in Europe beyond the evidence base and with insufficient device regulation. Concerns presented by Van Brabandt and colleagues included the cost and the learning curve associated with these new procedures. In addition they criticized the PARTNER trial because cost-effectiveness data had not been published, benefits in the subgroup undergoing TAVI by a transapical approach were less clear, and there were limitations in matching the treatment groups in Cohort B. Overall, Prof. Prendergast recommended that TAVI be considered in patients with indications for AVR who are high-risk for surgery as described by clinical trials and guidelines. In addition, he noted that it is important to consider which patients are less likely to benefit from TAVI, including those with a EuroSCORE >40, severe left or right ventricle impairment, severe respiratory disease, severe immobility, or life expectancy <1 year. Patients with EuroSCORE <10 are too low-risk to be considered for TAVI, especially if TAVI selection is driven by patient choice. Assessment by a comprehensive heart team, as was performed in the clinical trials, is strongly recommended to determine patient suitability for TAVI.
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Official Peer-Reviewed Highlights from the European Society of Cardiology Congress 2012
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Table of Contents for the Digital Edition of MD Conference Express ESC 2012
MD Conference Express ESC 2012
Contents
ESC 2012 Clinical Practice Guidelines
TAVI: 10 Years After the First Case
PARAMOUNT Trial Results
TRILOGY ACS Outcomes
Results from the ALTITUDE Trial
Results of the WOEST Trial
Results from the Aldo-DHF Trial
FAME 2 Results
Results from the IABP-SHOCK II Trial
STEMI Mortality Decreases in France While Some Key Risk Factors Increase
Results from the PURE Study
PURE: Treatment and Control of Hypertension
Genetic Determinants of Variability in Dabigatran Exposure
The RE-LY AF Registry
TRA 2°P-TIMI 50 Results
Rivaroxaban of Benefit in STEMI: ATLAS ACS 2-TIMI 51
Ivabradine Effect on Recurrent Hospitalization for HF
CLARIFY: Similar 1-Year Outcomes for Men and Women with Stable CAD
HPS2-THRIVE Study Results
PRoFESS Study Results
Outcomes from the CARDia Trial
Hypertension
Atrial Fibrillation
Heart Failure
MD Conference Express ESC 2012
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