Key result
Long-term clinical and hemodynamic outcomes were similar between self-expandable CoreValve and balloon-expandable Edwards SAPIEN transcatheter heart valves, with no significant difference in 30-day mortality and a late prosthesis failure rate under 3%.
Why the study?
Does TAVR with self-expandable CoreValve compared to balloon-expandable Edwards SAPIEN XT improve long-term clinical and hemodynamic outcomes in patients with severe symptomatic aortic stenosis?
Observational (n=171)
No
Does TAVR with self-expandable CoreValve compared to balloon-expandable Edwards SAPIEN XT improve long-term clinical and hemodynamic outcomes in patients with severe symptomatic aortic stenosis?
Both self-expandable and balloon-expandable transcatheter heart valves demonstrate favorable and comparable long-term clinical and hemodynamic outcomes up to 8 years, with a low rate of late prosthesis failure (<3%).
Answers are grounded in this paper and cite their sources.
Observational TAVR comparison of CV vs ES leaves open questions on long-term durability; randomized data needed before practice change.
BACKGROUND: Data on transcatheter aortic valve replacement (TAVR) long-term clinical outcomes and hemodynamic performance of the self-expandable CoreValve (CV) and the balloon-expandable Edwards SAPIEN XT (ES) (Edwards Lifesciences, Irvine, California, USA) transcatheter heart valves (THV) are limited. Therefore, this study aimed to compare long-term clinical outcome data and hemodynamic performance of TAVR with either CV or ES. METHODS: We reviewed prospectively collected data of 171 patients treated with TAVR for severe aortic stenosis (AS) at our center between June 2007 and December 2010, with last follow-up contact in 2016. RESULTS: Out of 171 patients treated with TAVR at our Institution, 87 received a CV and 84 an ES THV. Mean age was 81 [78-85] years, and mean Society of Thoracic Surgeons (STS) score was 7.5% (4.5-13.9%). Hemodynamic success by Valve Academic Research Consortium (VARC) definition was 97.1%. Mean trans-prosthetic gradient remained low and stable during follow-up in both groups (at 5-year 9.2±6.4 versus 12.7±5.1 mmHg, P=0.10). Late prosthesis failure occurred in 4 cases (2.4%). Thirty-day mortality was 4.7%, and estimated survival rates by Kaplan-Meyer after 1, 5 and 8 years were 87.6%, 44.9%, and 24.5%, respectively, without difference between THV groups. Rates of cardiovascular death, stroke, myocardial infarction (MI) and congestive heart failure (CHF) were also similar with CV and ES at long-term follow-up. History of CHF, pre-existent severe mitral regurgitation, paravalvular leak grade ≥2+, and chronic obstructive pulmonary disease were independent predictors of late mortality at multivariable analysis. CONCLUSIONS: Clinical and hemodynamic outcomes of patients treated by self-expandable CV or balloon-expandable ES THV were favorable and similar throughout long-term follow-up, with a rate of prosthesis failure of less than 3%.
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Tarantini et al. (2017) conducted an observational in Severe symptomatic aortic stenosis (n=171). Self-expandable CoreValve vs. Balloon-expandable Edwards SAPIEN XT was evaluated on 30-day all-cause mortality (p=0.72). Long-term clinical and hemodynamic outcomes were similar between self-expandable CoreValve and balloon-expandable Edwards SAPIEN transcatheter heart valves, with no significant difference in 30-day mortality and a late prosthesis failure rate under 3%.
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