Long-term Outcomes After TAVI
Long-term Outcomes After TAVI
Objectives This study sought to evaluate the long-term outcomes after transcatheter aortic valve implantation (TAVI) in the Multicenter Canadian Experience study, with special focus on the causes and predictors of late mortality and valve durability.
Background Very few data exist on the long-term outcomes associated with TAVI.
Methods This was a multicenter study including 339 patients considered to be nonoperable or at very high surgical risk (mean age: 81 ± 8 years; Society of Thoracic Surgeons score: 9.8 ± 6.4%) who underwent TAVI with a balloon-expandable Edwards valve (transfemoral: 48%, transapical: 52%). Follow-up was available in 99% of the patients, and serial echocardiographic exams were evaluated in a central echocardiography core laboratory.
Results At a mean follow-up of 42 ± 15 months 188 patients (55.5%) had died. The causes of late death (152 patients) were noncardiac (59.2%), cardiac (23.0%), and unknown (17.8%). The predictors of late mortality were chronic obstructive pulmonary disease (hazard ratio [HR]: 2.18, 95% confidence interval [CI]: 1.53 to 3.11), chronic kidney disease (HR: 1.08 for each decrease of 10 ml/min in estimated glomerular filtration rate, 95% CI: 1.01 to 1.19), chronic atrial fibrillation (HR: 1.44, 95% CI: 1.02 to 2.03), and frailty (HR: 1.52, 95% CI: 1.07 to 2.17). A mild nonclinically significant decrease in valve area occurred at 2-year follow-up (p < 0.01), but no further reduction in valve area was observed up to 4-year follow-up. No changes in residual aortic regurgitation and no cases of structural valve failure were observed during the follow-up period.
Conclusions Approximately one-half of the patients who underwent TAVI because of a high or prohibitive surgical risk profile had died at a mean follow-up of 3.5 years. Late mortality was due to noncardiac comorbidities in more than one-half of patients. No clinically significant deterioration in valve function was observed throughout the follow-up period.
Transcatheter aortic valve implantation (TAVI) has emerged as the treatment of choice in nonoperable patients with severe symptomatic aortic stenosis and a good alternative to surgery in those considered to be at high surgical risk. However, most data on TAVI are limited to acute and 1-year follow-up, and very few data exist on the outcomes beyond 1-year follow-up. Several factors have been identified as predictors of poorer early and midterm (1 year) outcomes after TAVI, but very few data exist on the factors determining worse outcomes at longer-term follow-up. Furthermore, the proper evaluation of transcatheter valve durability at long-term follow-up is one of the most important factors determining the potential expansion of this technology toward younger and lower-risk patients. Although TAVI is usually associated with excellent hemodynamic results, few data exist on the long-term durability of transcatheter valves. Importantly, the echocardiographic data available to date have been mainly obtained from single center studies or multicenter registries without central echocardiography core laboratory evaluation of the echocardiographic findings. The lack of uniformity in echocardiographic measurements might have introduced a bias in the evaluation of transcatheter valve hemodynamic status, including the degree and type of residual aortic regurgitation (AR). Also, the number of patients evaluated at different times over the follow-up period has tended to vary considerably, and this precludes a real paired evaluation of the echocardiographic exams, which in turn might lead to somewhat misleading results on valve durability. The objectives of this study were to evaluate the long-term outcomes after TAVI in the Multicenter Canadian experience study, with special focus on the causes and predictors of late mortality and valve durability.
Abstract and Introduction
Abstract
Objectives This study sought to evaluate the long-term outcomes after transcatheter aortic valve implantation (TAVI) in the Multicenter Canadian Experience study, with special focus on the causes and predictors of late mortality and valve durability.
Background Very few data exist on the long-term outcomes associated with TAVI.
Methods This was a multicenter study including 339 patients considered to be nonoperable or at very high surgical risk (mean age: 81 ± 8 years; Society of Thoracic Surgeons score: 9.8 ± 6.4%) who underwent TAVI with a balloon-expandable Edwards valve (transfemoral: 48%, transapical: 52%). Follow-up was available in 99% of the patients, and serial echocardiographic exams were evaluated in a central echocardiography core laboratory.
Results At a mean follow-up of 42 ± 15 months 188 patients (55.5%) had died. The causes of late death (152 patients) were noncardiac (59.2%), cardiac (23.0%), and unknown (17.8%). The predictors of late mortality were chronic obstructive pulmonary disease (hazard ratio [HR]: 2.18, 95% confidence interval [CI]: 1.53 to 3.11), chronic kidney disease (HR: 1.08 for each decrease of 10 ml/min in estimated glomerular filtration rate, 95% CI: 1.01 to 1.19), chronic atrial fibrillation (HR: 1.44, 95% CI: 1.02 to 2.03), and frailty (HR: 1.52, 95% CI: 1.07 to 2.17). A mild nonclinically significant decrease in valve area occurred at 2-year follow-up (p < 0.01), but no further reduction in valve area was observed up to 4-year follow-up. No changes in residual aortic regurgitation and no cases of structural valve failure were observed during the follow-up period.
Conclusions Approximately one-half of the patients who underwent TAVI because of a high or prohibitive surgical risk profile had died at a mean follow-up of 3.5 years. Late mortality was due to noncardiac comorbidities in more than one-half of patients. No clinically significant deterioration in valve function was observed throughout the follow-up period.
Introduction
Transcatheter aortic valve implantation (TAVI) has emerged as the treatment of choice in nonoperable patients with severe symptomatic aortic stenosis and a good alternative to surgery in those considered to be at high surgical risk. However, most data on TAVI are limited to acute and 1-year follow-up, and very few data exist on the outcomes beyond 1-year follow-up. Several factors have been identified as predictors of poorer early and midterm (1 year) outcomes after TAVI, but very few data exist on the factors determining worse outcomes at longer-term follow-up. Furthermore, the proper evaluation of transcatheter valve durability at long-term follow-up is one of the most important factors determining the potential expansion of this technology toward younger and lower-risk patients. Although TAVI is usually associated with excellent hemodynamic results, few data exist on the long-term durability of transcatheter valves. Importantly, the echocardiographic data available to date have been mainly obtained from single center studies or multicenter registries without central echocardiography core laboratory evaluation of the echocardiographic findings. The lack of uniformity in echocardiographic measurements might have introduced a bias in the evaluation of transcatheter valve hemodynamic status, including the degree and type of residual aortic regurgitation (AR). Also, the number of patients evaluated at different times over the follow-up period has tended to vary considerably, and this precludes a real paired evaluation of the echocardiographic exams, which in turn might lead to somewhat misleading results on valve durability. The objectives of this study were to evaluate the long-term outcomes after TAVI in the Multicenter Canadian experience study, with special focus on the causes and predictors of late mortality and valve durability.