Impact of early complications on outcomes in patients with implantable cardioverter-defibrillator for primary prevention.

BACKGROUND: The lifesaving benefit of implantable cardioverter-defibrillators (ICDs) has been demonstrated. Their use has increased considerably in the past decade, but related complications have become a major concern. OBJECTIVE: The purpose of this study was to assess the incidence and effect on outcomes of early (≤30 days) complications after ICD implantation for primary prevention in a large French population. METHODS: We analyzed data from 5539 patients from the multicenter French DAI-PP (Défibrillateur Automatique Implantable-Prévention Primaire) registry (2002-2012) who had coronary artery disease or dilated cardiomyopathy and were implanted with an ICD for primary prevention. RESULTS: Overall, early complications occurred in 707 patients (13.5%), mainly related to lead dislodgment or hematoma (57%). Independent factors associated with occurrence of early complications were severe renal impairment (odds ratio [OR] 1.66, 95% confidence interval [CI] 1.17-2.37, P = .02), age ≥75 years (OR 1.01, 95% CI 1.00-1.02, P = .03), cardiac resynchronization therapy (OR 1.58, 95% CI 1.16-2.17, P = .01), and anticoagulant therapy (OR 1.28, 95% CI 1.02-1.61, P = .03). During a mean ± SD follow-up of 3.1 ± 2.3 years, 824 (15.8%) patients experienced ≥1 late complication (>30 days), and 782 (14.9%) patients died. After adjustment, early complications remained associated with occurrence of late complications (OR 2.15, 95% CI 1.73-2.66, P < .0001) and mortality (OR 1.70, 95% CI 1.34-2.17, P = .003). CONCLUSION: Early complications are common after ICD implantation for primary prevention, occurring in 1 in 7 patients, and are associated with an increased risk of late complications and overall mortality. Further studies are needed to investigate the underlying mechanisms of such associations.

Prognostic value of NT-proBNP and an adapted monin score in patients with asymptomatic aortic stenosis.

INTRODUCTION AND OBJECTIVES: Our objective was to assess the prognostic value of NT-proBNP in patients with asymptomatic moderate/severe aortic stenosis and to validate an adapted Monin score using natriuretic peptide levels in our setting. METHODS: Prospective study of 237 patients with degenerative asymptomatic moderate/severe aortic stenosis. NT-proBNP was determined in all patients, who were then followed up clinically. The adapted Monin score was defined as follows: (peak velocity [m/s]×2)+(logn NT-proBNP×1.5)(+1.5 if woman). A clinical event was defined as surgery, hospital admission due to angina, heart failure or syncope, or death. RESULTS: A total of 51% were women, and the mean age was 74 years. Mean (SD) echocardiographic values were as follows: peak velocity 4.14 (0.87) m/s; mean gradient, 43.2 (16.0) mmHg; aortic valve area, 0.87 (0.72) cm(2), and aortic valve area index, 0.49 (0.14) cm(2)/m(2). The median NT-pro-BNP value was 490.0 [198.0-1312.0] pg/mL. There were 153 events during follow-up (median 18 months). The optimum NT-proBNP cut-point was 515 pg/mL, giving event-free survival rates at 1 and 2 years of 93% and 57%, respectively, in patients with NT-proBNP <515 pg/mL compared with 50% and 31% in those with NT-proBNP >515 pg/mL. Patients were divided into quartiles based on the Monin score. Event-free survival at 1 and 2 years was 87% and 79% in the first quartile, compared with 45% and 28% in the fourth quartile, respectively. CONCLUSIONS: NT-proBNP determination provides prognostic information in patients with asymptomatic moderate/severe aortic stenosis. The adapted Monin score is useful in our setting and allows a more precise prognosis than does the use of NT-proBNP alone.

Valor pronóstico de la NT-proBNP y adaptación de la puntuación de Monin en pacientes con estenosis aórtica asintomática / Prognostic value of NT-proBNP and an adapted monin score in patients with asymptomatic aortic stenosis

Introducción y objetivos. Los objetivos del estudio son valorar el papel de la NT-proBNP en la valoración pronóstica de los pacientes asintomáticos con estenosis aórtica moderada-grave y validar una adaptación de la puntuación de Monin a nuestra población. Métodos. Estudio prospectivo de 237 pacientes con estenosis aórtica degenerativa moderada-grave asintomática. Se determinó la NT-proBNP y se realizó un seguimiento clínico a todos los pacientes. Se calculó una adaptación de la puntuación de Monin como: (velocidad máxima [m/s] × 2) + (logn NT-proBNP × 1,5) (+ 1,5 si mujer). Se definió evento clínico como necesidad de cirugía valvular, ingreso hospitalario o muerte. Resultados. El 51% eran mujeres, con una media de edad de 74 años. Datos ecocardiográficos: velocidad máxima, 4,14 ± 0,87 m/s; gradiente medio, 43,2 ± 16,0 mmHg; área valvular aórtica, 0,87 ± 0,72 cm2; índice de área valvular aórtica, 0,49 ± 0,14 cm2/m2. La mediana de NT-proBNP fue 490,0 [198,0-1.312,0] pg/ml. Durante el seguimiento (mediana, 18 meses) 153 pacientes sufrieron eventos. El punto óptimo de corte de NT-proBNP fue 515 pg/ml, y se observaron supervivencias libres de eventos a 1 y 2 años del 93 y el 57% de los pacientes con NT-proBNP < 515 pg/ml frente al 50 y el 31% cuando la NT-proBNP era > 515 pg/ml. Se dividió a los pacientes en cuartiles de la puntuación de Monin. Las supervivencias libres de eventos a 1 y 2 años fueron del 87 y el 79% en el primer cuartil, frente al 45 y el 28% en el cuarto cuartil. Conclusiones. La NT-proBNP ofrece información pronóstica de pacientes asintomáticos con estenosis aórtica moderada-grave. La puntuación descrita por Monin es adaptable a nuestra población y mejora el valor pronóstico de la NT-proBNP sola (AU)

Introduction and objectives. Our objective was to assess the prognostic value of NT-proBNP in patients with asymptomatic moderate/severe aortic stenosis and to validate an adapted Monin score using natriuretic peptide levels in our setting. Methods. Prospective study of 237 patients with degenerative asymptomatic moderate/severe aortic stenosis. NT-proBNP was determined in all patients, who were then followed up clinically. The adapted Monin score was defined as follows: (peak velocity [m/s]×2)+(logn NT-proBNP×1.5)(+1.5 if woman). A clinical event was defined as surgery, hospital admission due to angina, heart failure or syncope, or death. Results. A total of 51% were women, and the mean age was 74 years. Mean (SD) echocardiographic values were as follows: peak velocity 4.14 (0.87) m/s; mean gradient, 43.2 (16.0) mmHg; aortic valve area, 0.87 (0.72) cm2, and aortic valve area index, 0.49 (0.14) cm2/m2. The median NT-pro-BNP value was 490.0 [198.0-1312.0] pg/mL. There were 153 events during follow-up (median 18 months). The optimum NT-proBNP cut-point was 515 pg/mL, giving event-free survival rates at 1 and 2 years of 93% and 57%, respectively, in patients with NT-proBNP <515 pg/mL compared with 50% and 31% in those with NT-proBNP >515 pg/mL. Patients were divided into quartiles based on the Monin score. Event-free survival at 1 and 2 years was 87% and 79% in the first quartile, compared with 45% and 28% in the fourth quartile, respectively. Conclusions. NT-proBNP determination provides prognostic information in patients with asymptomatic moderate/severe aortic stenosis. The adapted Monin score is useful in our setting and allows a more precise prognosis than does the use of NT-proBNP alone (AU)