Bicuspid aortic valve (BAV) disease affects 1%-2% of the population and manifests with severe aortic stenosis in the middle-aged.
It characterizes for a very different anatomy with more calcification than the tricuspid aortic valve. At present, surgical aortic valve replacement (SAVR) is the first treatment indication.
TAVR in this scenario has shown, in different studies, very similar evolution vs SAVR. However, it has been associated with higher presence of paravalvular leak, greater need for pacemaker implantation, especially when using first generation valves, both with balloon expanding (BEV) and self-expandable (SEV). Also, data on long term efficacy are scarce.
This was a retrospective analysis of 150 patients with severe aortic stenosis for BAV disease undergoing TAVR. 83 of these patients received SEV (CoreValve, CoreValve Evolut R, CoreValve Evolut PRO) and 67 BEV (Edwards Lifesciences Sapien 3 Valve).
Primary end point was a composite of all-cause death, stroke or need for reintervention at 3 years.
Read also: Acute Myocardial Infarction After TAVI: Retrospective Analysis of >200,000 Implants.
Mean age was 81, and 32% were women. Morality STS was 5.4%, 15% presented diabetes, 75% hypertension, and 8% stroke. Estimated glomerular filtration (eGFR) was 60 ml/min, with 17% RBBB and 18% LBBB. BEV patients received coronary angioplasty more often, and they had higher incidence of atrial fibrillation (46.3% vs. 27.7% p=0.019) and first degree AV block (14.9% vs. 4.8% p=0.034).
BEV patients presented lower ventricular function (50% vs. 57%, p=0.002), and smaller aortic valve area (0.68 cm2 vs. 0.76 cm2, p=0.004). There were no significant differences in bicuspid valve type or calcification severity, but BEV patients had greater perimeter an annular area.
Implantation success rate was similar, but SEV patients required more pre and post dilation.
Read also: Reinterventions in TAVR with Self-Expanding Valves.
At 30-day and one year followup, there were no differences in cardiovascular or all-cause mortality, stroke or need for permanent pacemaker implantation. However, gradient was lower among SEV patients, but there was a higher presence of ≥moderate regurgitation, with no statistical significance.
At 3 years, there were no differences in primary end point (35.9% vs. 32%, p=0.660 for SEV and BEV, respectively). Neither were there differences in all-cause mortality, cardiovascular mortality, stroke, reintervention, paravalvular leak, or the need for permanent pacemaker implantation. There was a tendency towards a lower gradient in SEV patients (8.8 mmHg vs. 10.3 mmHg, p=0.063).
Conclusion
This single center study showed favorable 3-year evolution in unselected patients with aortic stenosis with bicuspid valve treated with different generation devices, with no difference between SEV or BEV cohorts.
Dr. Carlos Fava.
Member of the Editorial Board of SOLACI.org.
Reference: Mauro Boiago, et al. Catheter Cardiovasc Interv. 2024;103:1004–1014.
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