TAVI Acute and Late Outcomes Reported in Canadian Experience

January 20, 2010—Josep Rodés-Cabau, MD, et al have published acute and late outcomes of transcatheter aortic valve implantation (TAVI) for treating severe symptomatic aortic stenosis in patients who are at very high or prohibitive surgical risk in a multicenter Canadian experience. The study was published online ahead of print in the Journal of the American College of Cardiology.

According to the investigators, there were two aims of this study. One aim was to evaluate the acute and late outcomes of a TAVI program, including both the transfemoral (TF) and transapical (TA) approaches. The second aim was to determine the results of TAVI in patients deemed inoperable because of either porcelain aorta or frailty. The background of the study is that very few data exist on the results of a comprehensive TAVI program, including both TA and TF approaches for treating severe aortic stenosis in patients who are at very high or prohibitive surgical risk.

The investigators concluded that a TAVI program including both TF and TA approaches was associated with comparable mortality as predicted by surgical risk calculators for treating patients at very high or prohibitive surgical risk, including porcelain aorta and frail patients. They stated that baseline (pulmonary hypertension, chronic kidney disease, chronic obstructive pulmonary disease) and periprocedural (hemodynamic support, sepsis) factors, but not the approach, determined worse outcomes.

As detailed in the Journal of the American College of Cardiology, the study included consecutive patients who underwent TAVI with either the Cribier-Edwards valve or the Edwards Sapien valve (Edwards Lifesciences, Irvine, CA) between January 2005 and June 2009 in six Canadian centers. 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 investigators reported that 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, 3–14 months) the mortality rate was 22.1%. The predictors of cumulative late mortality were periprocedural sepsis (hazard ratio [HR], 3.49; 95% confidence interval [CI], 1.48–8.28) or need for hemodynamic support (HR, 2.58; 95% CI, 1.11–6), pulmonary hypertension (HR, 1.88; 95% CI, 1.17–3), chronic kidney disease (HR, 2.3; 95% CI, 1.38–3.84), and chronic obstructive pulmonary disease (HR, 1.75; 95% CI, 1.09–2.83). 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, the investigators found.