title: Cardiac resynchronization therapy in women versus men: observational comparative effectiveness study from the National Cardiovascular Data Registry.
abstract: BACKGROUND
  Women have been under-represented in trials of cardiac resynchronization therapy-defibrillators (CRT-D). Previous studies suggest that women benefit from CRT-D at shorter QRS duration than men and that there may be no benefit of CRT-D in patients without left bundle branch block (LBBB) regardless of patient sex.
  
  
  RESULTS
  We compared sex-specific death risk in 75 079 patients with New York Heart Association class III or IV heart failure, reduced left ventricular ejection fraction, and prolonged QRS duration (≥120 ms) receiving either CRT-D or implantable cardioverter defibrillator in subgroups according to QRS morphology and 10-ms increments in QRS duration. We applied propensity score weighting to control for differences between treatments. Among patients with LBBB, women receiving CRT-D had a lower relative death risk than those receiving an implantable cardioverter-defibrillator (absolute difference, 11%; hazard ratio=0.74 [95% confidence interval, 0.68-0.81]). In men, the lower mortality with CRT-D versus implantable cardioverter defibrillator was less pronounced (absolute difference, 9%; hazard ratio=0.84 [0.79-0.89]; sex×device interaction P=0.025). In those without LBBB, the mortality difference was modest and did not differ between women and men (absolute difference, 3%; hazard ratio=0.88 [0.79-0.97] in women and absolute difference, 2%; hazard ratio=0.95 [0.91-0.998] in men; interaction P=0.17). In subgroups according to QRS duration, CRT-D was associated with better survival in both sexes with LBBB and QRS ≥130 ms, whereas there was no clear relation between QRS duration and survival in patients without LBBB regardless of patient sex.
  
  
  CONCLUSIONS
  In a large real-world population CRT-D was associated with a lower mortality risk in both sexes with LBBB, although more pronounced among women. Only among those with LBBB, both sexes had better survival with longer QRS duration. The mortality differences in patients without LBBB were attenuated in both sexes.
authors.affiliation: From the Center for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, MD (R.Z., W.E.S., K.A.S., I.L.P., D.A.C., D.G.S.); Yale School of Medicine, New Haven, CT (E.S.S., J.P.C., H.B.); American College of Cardiology Foundation, Washington, DC (A.P.); VA Eastern Colorado Health Care System, University of Colorado, Denver (P.D.V.); Colorado Cardiovascular Outcomes Research Group, Denver (P.D.V.); and University of Colorado Anschutz Medical Campus, Aurora (F.A.M.).
authors.forename: Robbert
authors.initials: R
authors.lastname: Zusterzeel
authors.affiliation: From the Center for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, MD (R.Z., W.E.S., K.A.S., I.L.P., D.A.C., D.G.S.); Yale School of Medicine, New Haven, CT (E.S.S., J.P.C., H.B.); American College of Cardiology Foundation, Washington, DC (A.P.); VA Eastern Colorado Health Care System, University of Colorado, Denver (P.D.V.); Colorado Cardiovascular Outcomes Research Group, Denver (P.D.V.); and University of Colorado Anschutz Medical Campus, Aurora (F.A.M.).
authors.forename: Erica S
authors.initials: ES
authors.lastname: Spatz
authors.affiliation: From the Center for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, MD (R.Z., W.E.S., K.A.S., I.L.P., D.A.C., D.G.S.); Yale School of Medicine, New Haven, CT (E.S.S., J.P.C., H.B.); American College of Cardiology Foundation, Washington, DC (A.P.); VA Eastern Colorado Health Care System, University of Colorado, Denver (P.D.V.); Colorado Cardiovascular Outcomes Research Group, Denver (P.D.V.); and University of Colorado Anschutz Medical Campus, Aurora (F.A.M.).
authors.forename: Jeptha P
authors.initials: JP
authors.lastname: Curtis
authors.affiliation: From the Center for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, MD (R.Z., W.E.S., K.A.S., I.L.P., D.A.C., D.G.S.); Yale School of Medicine, New Haven, CT (E.S.S., J.P.C., H.B.); American College of Cardiology Foundation, Washington, DC (A.P.); VA Eastern Colorado Health Care System, University of Colorado, Denver (P.D.V.); Colorado Cardiovascular Outcomes Research Group, Denver (P.D.V.); and University of Colorado Anschutz Medical Campus, Aurora (F.A.M.).
authors.forename: William E
authors.initials: WE
authors.lastname: Sanders
authors.affiliation: From the Center for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, MD (R.Z., W.E.S., K.A.S., I.L.P., D.A.C., D.G.S.); Yale School of Medicine, New Haven, CT (E.S.S., J.P.C., H.B.); American College of Cardiology Foundation, Washington, DC (A.P.); VA Eastern Colorado Health Care System, University of Colorado, Denver (P.D.V.); Colorado Cardiovascular Outcomes Research Group, Denver (P.D.V.); and University of Colorado Anschutz Medical Campus, Aurora (F.A.M.).
authors.forename: Kimberly A
authors.initials: KA
authors.lastname: Selzman
authors.affiliation: From the Center for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, MD (R.Z., W.E.S., K.A.S., I.L.P., D.A.C., D.G.S.); Yale School of Medicine, New Haven, CT (E.S.S., J.P.C., H.B.); American College of Cardiology Foundation, Washington, DC (A.P.); VA Eastern Colorado Health Care System, University of Colorado, Denver (P.D.V.); Colorado Cardiovascular Outcomes Research Group, Denver (P.D.V.); and University of Colorado Anschutz Medical Campus, Aurora (F.A.M.).
authors.forename: Ileana L
authors.initials: IL
authors.lastname: Piña
authors.affiliation: From the Center for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, MD (R.Z., W.E.S., K.A.S., I.L.P., D.A.C., D.G.S.); Yale School of Medicine, New Haven, CT (E.S.S., J.P.C., H.B.); American College of Cardiology Foundation, Washington, DC (A.P.); VA Eastern Colorado Health Care System, University of Colorado, Denver (P.D.V.); Colorado Cardiovascular Outcomes Research Group, Denver (P.D.V.); and University of Colorado Anschutz Medical Campus, Aurora (F.A.M.).
authors.forename: Haikun
authors.initials: H
authors.lastname: Bao
authors.affiliation: From the Center for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, MD (R.Z., W.E.S., K.A.S., I.L.P., D.A.C., D.G.S.); Yale School of Medicine, New Haven, CT (E.S.S., J.P.C., H.B.); American College of Cardiology Foundation, Washington, DC (A.P.); VA Eastern Colorado Health Care System, University of Colorado, Denver (P.D.V.); Colorado Cardiovascular Outcomes Research Group, Denver (P.D.V.); and University of Colorado Anschutz Medical Campus, Aurora (F.A.M.).
authors.forename: Angelo
authors.initials: A
authors.lastname: Ponirakis
authors.affiliation: From the Center for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, MD (R.Z., W.E.S., K.A.S., I.L.P., D.A.C., D.G.S.); Yale School of Medicine, New Haven, CT (E.S.S., J.P.C., H.B.); American College of Cardiology Foundation, Washington, DC (A.P.); VA Eastern Colorado Health Care System, University of Colorado, Denver (P.D.V.); Colorado Cardiovascular Outcomes Research Group, Denver (P.D.V.); and University of Colorado Anschutz Medical Campus, Aurora (F.A.M.).
authors.forename: Paul D
authors.initials: PD
authors.lastname: Varosy
authors.affiliation: From the Center for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, MD (R.Z., W.E.S., K.A.S., I.L.P., D.A.C., D.G.S.); Yale School of Medicine, New Haven, CT (E.S.S., J.P.C., H.B.); American College of Cardiology Foundation, Washington, DC (A.P.); VA Eastern Colorado Health Care System, University of Colorado, Denver (P.D.V.); Colorado Cardiovascular Outcomes Research Group, Denver (P.D.V.); and University of Colorado Anschutz Medical Campus, Aurora (F.A.M.).
authors.forename: Frederick A
authors.initials: FA
authors.lastname: Masoudi
authors.affiliation: From the Center for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, MD (R.Z., W.E.S., K.A.S., I.L.P., D.A.C., D.G.S.); Yale School of Medicine, New Haven, CT (E.S.S., J.P.C., H.B.); American College of Cardiology Foundation, Washington, DC (A.P.); VA Eastern Colorado Health Care System, University of Colorado, Denver (P.D.V.); Colorado Cardiovascular Outcomes Research Group, Denver (P.D.V.); and University of Colorado Anschutz Medical Campus, Aurora (F.A.M.).
authors.forename: Daniel A
authors.initials: DA
authors.lastname: Caños
authors.affiliation: From the Center for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, MD (R.Z., W.E.S., K.A.S., I.L.P., D.A.C., D.G.S.); Yale School of Medicine, New Haven, CT (E.S.S., J.P.C., H.B.); American College of Cardiology Foundation, Washington, DC (A.P.); VA Eastern Colorado Health Care System, University of Colorado, Denver (P.D.V.); Colorado Cardiovascular Outcomes Research Group, Denver (P.D.V.); and University of Colorado Anschutz Medical Campus, Aurora (F.A.M.). david.strauss@fda.hhs.gov.
authors.forename: David G
authors.initials: DG
authors.lastname: Strauss
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D002037:Bundle-Branch Block / Q000175:diagnosis / Q000401:mortality / Q000503:physiopathology / Q000628:therapy*; D058406:Cardiac Resynchronization Therapy / Q000009:adverse effects / Q000401:mortality; D058409:Cardiac Resynchronization Therapy Devices; D017147:Defibrillators, Implantable; D004554:Electric Countershock / Q000009:adverse effects / Q000295:instrumentation / Q000401:mortality; D005260:Female; D054624:Health Status Disparities; D006329:Heart Conduction System / Q000503:physiopathology*; D006333:Heart Failure / Q000175:diagnosis / Q000401:mortality / Q000503:physiopathology / Q000628:therapy*; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D057216:Propensity Score; D016016:Proportional Hazards Models; D012042:Registries; D012307:Risk Factors; D012737:Sex Factors; D013318:Stroke Volume; D016896:Treatment Outcome; D014481:United States; D016277:Ventricular Function, Left
keywords: bundle-branch block; cardiac resynchronization therapy; sex