Three-Year Outcomes With a Contemporary Self-Expanding Transcatheter Valve From the Evolut PRO US Clinical Study.
Cardiovasc Revasc Med
; 26: 12-16, 2021 05.
Article
en En
| MEDLINE
| ID: mdl-33199247
ABSTRACT
BACKGROUND:
Paravalvular regurgitation (PVR) following transcatheter aortic valve replacement (TAVR) is associated with increased morbidity and mortality. PVR continues to plague TAVR jeopardizing long-term results. New device iterations, such as the self-expandable Evolut PRO valve, aim to decrease PVR while maintaining optimal hemodynamics. This study sought to evaluate clinical and hemodynamic performance of the Evolut PRO system at 3 years.METHODS:
The Evolut PRO US Clinical Study included 60 patients at high or extreme surgical risk undergoing TAVR with the Evolut PRO valve at 8 centers in the United States. Clinical outcomes were evaluated using Valve Academic Research Consortium (VARC)-2 criteria and included all-cause mortality, cardiovascular mortality, disabling stroke and valve complications. An independent core laboratory centrally assessed all echocardiographic measures.RESULTS:
At 3 years, all-cause mortality was 25.8% (cardiovascular mortality 16.5%) and the disabling stroke rate was 10.7%. There were no cases of repeat valve intervention, endocarditis or coronary obstruction. Valve thrombosis was identified in 1 patient 2 years post-procedure and was treated medically. Hemodynamics at 3 years included a mean gradient of 7.2 ± 4.5 mm Hg, an effective orifice area of 2.0 ± 0.5 cm2, and 88.2% of patients had no or trace PVR. The remaining patients had mild PVR. Most of the surviving patients (80.6%) had New York Heart Association class I symptoms at 3 years.CONCLUSION:
Outcomes at 3-years following TAVR with a contemporary self-expanding prosthesis are favorable, with no signal of valve deterioration, excellent hemodynamics including very low prevalence of PVR.Palabras clave
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Estenosis de la Válvula Aórtica
/
Prótesis Valvulares Cardíacas
/
Reemplazo de la Válvula Aórtica Transcatéter
Tipo de estudio:
Etiology_studies
/
Prognostic_studies
/
Risk_factors_studies
Límite:
Humans
País/Región como asunto:
America do norte
Idioma:
En
Revista:
Cardiovasc Revasc Med
Asunto de la revista:
ANGIOLOGIA
/
CARDIOLOGIA
Año:
2021
Tipo del documento:
Article