Key result
TAVI yields ~10% 30-day mortality in prohibitive surgical risk patients.
Why the study?
Very few data exist on the acute and late outcomes of a comprehensive TAVI program using both TF and TA approaches in patients at very high or prohibitive surgical risk, including inoperable patients with porcelain aorta or frailty.
Does transcatheter aortic valve implantation (TAVI) provide acceptable acute and late outcomes in patients with severe symptomatic aortic stenosis at very high or prohibitive surgical risk?
Cohort (n=339)
Yes
Does transcatheter aortic valve implantation (TAVI) provide acceptable acute and late outcomes in patients with severe symptomatic aortic stenosis at very high or prohibitive surgical risk?
A comprehensive TAVI program including both transfemoral and transapical approaches yields acceptable procedural success and mortality rates in patients with severe aortic stenosis at prohibitive surgical risk.
Supports TAVI feasibility in prohibitive-risk patients; leaves open comparative effectiveness and durability versus contemporary therapies.
OBJECTIVES: The aim of this study was: 1) to evaluate the acute and late outcomes of a transcatheter aortic valve implantation (TAVI) program including both the transfemoral (TF) and transapical (TA) approaches; and 2) to determine the results of TAVI in patients deemed inoperable because of either porcelain aorta or frailty. BACKGROUND: Very few data exist on the results of a comprehensive TAVI program including both TA and TF approaches for the treatment of severe aortic stenosis in patients at very high or prohibitive surgical risk. METHODS: Consecutive patients who underwent TAVI with the Edwards valve (Edwards Lifesciences, Inc., Irvine, California) between January 2005 and June 2009 in 6 Canadian centers were included. RESULTS: A total of 345 procedures (TF: 168, TA: 177) were performed in 339 patients. The predicted surgical mortality (Society of Thoracic Surgeons risk score) was 9.8 +/- 6.4%. The procedural success rate was 93.3%, and 30-day mortality was 10.4% (TF: 9.5%, TA: 11.3%). After a median follow-up of 8 months (25th to 75th interquartile range: 3 to 14 months) the mortality rate was 22.1%. The predictors of cumulative late mortality were peri-procedural sepsis (hazard ratio [HR]: 3.49, 95% confidence interval [CI]: 1.48 to 8.28) or need for hemodynamic support (HR: 2.58, 95% CI: 1.11 to 6), pulmonary hypertension (PH) (HR: 1.88, 95% CI: 1.17 to 3), chronic kidney disease (CKD) (HR: 2.30, 95% CI: 1.38 to 3.84), and chronic obstructive pulmonary disease (COPD) (HR: 1.75, 95% CI: 1.09 to 2.83). Patients with either porcelain aorta (18%) or frailty (25%) exhibited acute outcomes similar to the rest of the study population, and porcelain aorta patients tended to have a better survival rate at 1-year follow-up. CONCLUSIONS: A TAVI program including both TF and TA approaches was associated with comparable mortality as predicted by surgical risk calculators for the treatment of patients at very high or prohibitive surgical risk, including porcelain aorta and frail patients. Baseline (PH, COPD, CKD) and peri-procedural (hemodynamic support, sepsis) factors but not the approach determined worse outcomes.
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Rodés‐Cabau et al. (2010) conducted a cohort in Severe symptomatic aortic stenosis at very high or prohibitive surgical risk (n=339). Transcatheter aortic valve implantation (TAVI) was evaluated on 30-day mortality. Transcatheter aortic valve implantation in patients at very high or prohibitive surgical risk achieved a 93.3% procedural success rate and a 10.4% 30-day mortality rate.
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