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Transcatheter aortic valve implantation: 3-year outcomes of self-expanding CoreValve prosthesis
Gian Paolo Ussia1, Marco Barbanti, Anna Sonia Petronio
1Interventional Structural and Congenital Heart Disease Programme, Invasive Cardiology Division of Cardiology, Ferrarotto Hospital, University of Catania, Catania, Italy. gpussia@hotmail.com
Insights
Transcatheter aortic valve implantation (TAVI) with the CoreValve prosthesis shows sustained benefits up to 3 years in high-risk patients. Echocardiographic improvements were maintained, but mortality remains a concern, especially with renal insufficiency or bleeding events.
Area of Science:
- Cardiovascular Medicine
- Interventional Cardiology
- Prosthetic Valve Technology
Background:
- Limited data exists on the long-term durability of transcatheter aortic valve implantation (TAVI) prostheses.
- Assessing the 3-year outcomes of the third-generation CoreValve prosthesis is crucial for understanding its long-term performance.
Purpose of the Study:
- To evaluate the 3-year clinical and echocardiographic outcomes of patients who underwent TAVI using the third-generation CoreValve prosthesis.
- To assess the long-term durability and safety of this TAVI device in high-risk patients.
Main Methods:
- Analysis of 181 patients from the Italian CoreValve registry who underwent TAVI between June 2007 and August 2008 and had 3-year follow-up.
- Outcomes defined according to Valve Academic Research Consortium (VARC) criteria.
- Evaluation of all-cause and cardiovascular mortality, composite endpoints, and echocardiographic parameters (gradients, valve area).
Main Results:
- All-cause mortality at 3 years was 34.8%, and cardiovascular death was 13.5%.
- Actuarial survival free from major adverse events was 59.7% at 3 years.
- Significant improvements in mean aortic pressure gradients and aortic valve area were sustained at 3 years post-TAVI.
- Higher mortality observed in patients with renal insufficiency (49.0%) and those experiencing major bleeding (62.2%).
- No moderate/severe paravalvular leak progression or structural valve deterioration reported.
Conclusions:
- TAVI with the 18-Fr CoreValve ReValving System provides sustained clinical and functional cardiovascular benefits up to 3 years in high-risk patients with symptomatic aortic stenosis.
- Non-cardiac causes were the primary drivers of mortality at follow-up.
- Renal insufficiency and bleeding complications are associated with increased long-term mortality.
Aims:
The paucity of evidences about the long-term durability of currently available transcatheter prostheses is one of the main issues of transcatheter aortic valve implantation (TAVI). We sought to assess 3-year clinical and echocardiographic outcomes of patients undergoing TAVI with the third generation CoreValve prosthesis (Medtronic Incorporation, MN, USA).
Methods And Results:
From the Italian CoreValve registry, 181 who underwent TAVI from June 2007 to August 2008 and eligible for 3-year follow-up were analysed. All outcomes were defined according to the Valve Academic Research Consortium. All-cause mortality at 1, 2, and 3 years was 23.6, 30.3, and 34.8%, respectively. Cardiovascular death at 1, 2, and 3 years was 11.2, 12.1, and 13.5%, respectively. The actuarial survival free from a composite of death, major stroke, myocardial infarction, and life-threatening bleeding was 69.6% at 1 year, 63.5% at 2 years, and 59.7% at 3 years. Patients with renal insufficiency had a higher mortality at 3-year follow-up (49.0 vs. 29.2%, P = 0.007); moreover, patients experiencing post-procedural major or life-threatening bleeding had a higher rate of mortality already seen at 30 days (21.6 vs. 2.8%; P < 0.001) and this result was sustained at 3-year follow-up (62.2 vs. 27.7%; P < 0.001). Mean pressure gradients decreased from 52.2 ± 18.1 mmHg (pre-TAVI) to 10.3 ± 3.1 mmHg (1-year post-TAVI) (P < 0.001); aortic valve area increased from 0.6 ± 0.2 cm(2) (pre-TAVI) to 1.8 ± 0.4 cm(2) (1-year post-TAVI); these results remained stable over the 3 years of follow-up. Paravalvular leak was observed in the majority of patients. There were no cases of progression to moderate or severe regurgitation. No cases of structural valve deterioration were observed.
Conclusion:
This multicentre study demonstrates that TAVI with the 18-Fr CoreValve ReValving System is associated with sustained clinical and functional cardiovascular benefits in high-risk patients with symptomatic aortic stenosis up to 3-year follow-up. Non-cardiac causes accounted for the majority of deaths at follow-up.
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