Left Atrial to Coronary Sinus Shunting for Treatment of Symptomatic Heart Failure.
JACC Cardiovasc Interv
; 16(11): 1369-1380, 2023 06 12.
Article
en En
| MEDLINE
| ID: mdl-36989271
ABSTRACT
BACKGROUND:
Heart failure (HF) is associated with both mortality and a significant decline in health status. Interatrial shunting is increasingly being investigated as a novel therapeutic option.OBJECTIVES:
The ALT FLOW Early Feasibility Study was designed to evaluate the safety of the Edwards left atrial to coronary sinus APTURE Transcatheter Shunt System in patients with symptomatic HF.METHODS:
A total of 18 centers enrolled patients with symptomatic HF with a pulmonary capillary wedge pressure >15 mm Hg at rest or 25 mm Hg during exercise.RESULTS:
Between May 2018 and September 2022, 87 patients underwent attempted APTURE shunt implantation. Mean age was 71 years, and 53% were male. At baseline, mean left ventricular ejection fraction was 59% with 90% of the patients being in NYHA functional class III. Device success was achieved in 78 patients (90%), with no device occlusions or associated adverse events identified after implantation. The primary safety outcome occurred in only 2 patients (2.3%) at 30 days. At 6 months, health status improved 67% of participants achieved NYHA functional class I to II status, with a 23-point improvement (P < 0.0001; 95% CI 17-29 points) in the Kansas City Cardiomyopathy Questionnaire overall summary score. Also at 6 months, 20-W exercise pulmonary capillary wedge pressure was 7 mm Hg lower (P < 0.0001; 95% CI -11 to -4 mm Hg) without change in right atrial pressure or other right heart function indices.CONCLUSIONS:
In this single-arm experience, the APTURE Transcatheter Shunt System in patients with symptomatic HF was observed to be safe and resulted in reduction in pulmonary capillary wedge pressure and clinically meaningful improvements in HF symptoms and quality of life indices.Palabras clave
Texto completo:
1
Bases de datos:
MEDLINE
Asunto principal:
Fibrilación Atrial
/
Seno Coronario
/
Insuficiencia Cardíaca
Tipo de estudio:
Diagnostic_studies
/
Etiology_studies
/
Prognostic_studies
Límite:
Aged
/
Female
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Humans
/
Male
Idioma:
En
Revista:
JACC Cardiovasc Interv
Asunto de la revista:
ANGIOLOGIA
/
CARDIOLOGIA
Año:
2023
Tipo del documento:
Article
País de afiliación:
Canadá