Scientific Publications by FDA Staff
JACC Heart Fail 2013 Jun;1(3):237-44
Left bundle branch block predicts better survival in women than men receiving cardiac resynchronization therapy: long-term follow-up of approximately 145,000 patients.
Loring Z, Canos DA, Selzman K, Herz ND, Silverman H, Macurdy TE, Worrall CM, Kelman J, Ritchey ME, Pina IL, Strauss DG
OBJECTIVES: The goal of this study was to test the hypothesis that in recipients of cardiac resynchronization therapy defibrillators (CRT-D), conventional left bundle branch block (LBBB) diagnosis predicts better survival in women than in men. BACKGROUND: New York Heart Association class I and II patients without LBBB do not benefit from CRT-D, and women have better survival after CRT-D than men. Separate analysis suggests that QRS duration thresholds for LBBB diagnosis differ according to sex, and conventional LBBB electrocardiographic criteria are falsely positive in men more frequently than in women. METHODS: We analyzed Medicare records from 144,642 CRT-D recipients between 2002 and 2008 that were followed up for up to 90 months. Medicare billing data were used to determine age, sex, race, and comorbidities. Hazard ratios (HRs) were calculated to assess if conventional LBBB diagnosis had different prognostic significance according to sex. RESULTS: In univariate analysis, LBBB was associated with a 31% reduction in death in women (HR: 0.69 [95% confidence interval (CI): 0.67 to 0.71]) but only a 16% reduction in death in men (HR: 0.84 [95% CI: 0.82 to 0.85]). In multivariable analyses controlling for comorbidities, LBBB was associated with a 26% reduction in death in women (HR: 0.74 [95% CI: 0.71 to 0.77]) and a 15% reduction in death in men (HR: 0.85 [95% CI: 0.83 to 0.87]). A significant interaction (p < 0.0001) between sex and LBBB was seen. CONCLUSIONS: LBBB diagnosis is associated with greater survival in women than in men receiving CRT-D, and this discrepancy is not explained by differences in measured comorbidities. Possible explanations for this difference include that LBBB may have different prognostic significance according to sex or that LBBB diagnosis is more often false-positive in men compared with women.
|Category: Journal Article|
|PubMed ID: #24621876||DOI: 10.1016/j.jchf.2013.03.005|
|Includes FDA Authors from Scientific Area(s): Medical Devices|
|Entry Created: 2014-03-14||Entry Last Modified: 2014-05-10|